Infection
Conditions
Keywords
Complicated Intra-Abdominal Infections
Brief summary
A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.
Interventions
Moxifloxacin, 400mg, administered intravenously once daily
DRUGErtapenem intravenous
Active treatment: Ertapenem 1.0g, administered intravenously once daily
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized men or women \>/=18 years of age * Expected duration of treatment with intravenous antibiotics anticipated to be \>/= 5 full days but not exceeding 14 days * Ability to provide documented and signed written informed consent * Confirmed or suspected intra abdominal infection defined as follows: * For a confirmed intra abdominal infection, a surgical procedure (laparotomy or laparoscopy) must have been performed within 24 hours prior to enrollment and reveal at least one of the following: * Gross peritoneal inflammation with purulent exudates (i.e. peritonitis) * Intra abdominal abscess * Macroscopic intestinal perforation with localized or diffuse peritonitis * Subjects enrolled on the basis of a suspected intra abdominal infection must have: * Radiological evidence \[abdominal plain films, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound\] of gastrointestinal perforation or intra-abdominal abscess and the following signs and symptoms: * Symptoms referable to the abdominal cavity (e.g. anorexia, nausea, vomiting or pain), lasting for at least 24 hours * Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity * At least two of the following SIRS criteria: * Temperature \> 38.0°C rectal or tympanic membrane, or temperature \< 36.0°C rectal or tympanic * Heart rate \> 90/min * Respiratory rate \> 20/min * WBC \>12,000 cells/mm3 or \< 4,000 cells/ mm3 * The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) within 24 hours of enrollment of the study
Exclusion criteria
* Known hypersensitivity to quinolones, and/or to carbapenems and/or to any other type of beta lactam antibiotic drugs (e.g. penicillins or cephalosporins), or any of the excipients * Women who are pregnant or lactating or in whom pregnancy cannot be excluded * History of tendon disease/disorder related to quinolone treatment * Known congenital or documented acquired QT prolongation; uncorrected hypokalemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left ventricular ejection fraction; previous history of symptomatic arrhythmias * Concomitant use of any of the following drugs, reported to increase the QT interval: antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (e.g., amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressive agents, certain antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarials, particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), and others (cisapride, vincamine IV, bepridil, diphemanil) * Known severe end stage liver disease * Creatinine clearance \</= 30 mL/min/1.73 m2 * Systemic antibacterial therapy administered for more than 24 hours within 7 days of enrollment * Need for systemic antibacterial therapy with agents other than those described in the study protocol * Indwelling peritoneal catheter * Pre existing ascites and presumed spontaneous bacterial peritonitis * Perforation of the stomach or duodenum, if the duration of perforation is less than 24 hours or if operated on within 24 hours of perforation * Perforation of the small bowel (excluding the duodenum) or large bowel, if the duration of perforation is less than 12 hours or if operated on within 12 hours of perforation * All pancreatic processes including pancreatic sepsis, peri-pancreatic sepsis, or an intra abdominal infection secondary to pancreatitis * Liver and splenic abscess * Transmural bowel ischemia or necrosis without perforation or established peritonitis or abscess * Acute and gangrenous cholecystitis without perforation * Acute cholangitis * Early acute, suppurative, or gangrenous non-perforated appendicitis * Subjects requiring antibiotic irrigations of the abdominal cavity or surgical wound * Treatment with open abdomen or marsupialization, or multiple planned re laparotomies * Infections originating from the female genital tract * Peri-nephric infections * Evidence of sepsis with shock requiring the administration of vasopressors for more than 4 consecutive hours * Known rapidly fatal underlying disease (death expected within 6 months) * Neutropenia (neutrophil count \< 1,000/mL) caused by immunosuppressive therapy or malignancy * Receiving chronic treatment with known immunosuppressant therapy (including chronic treatment with \> 15 mg/day of systemic prednisone or equivalent) * Subjects known to have AIDS (CD4 count \< 200/mL) or HIV seropositives who are receiving HAART (HIV positive subjects may be included. HIV testing is not required for this study protocol) * Subjects with a malignant or pre malignant hematological condition, including Hodgkin's disease and non-Hodgkin lymphoma (subjects with solid tumor can be included in the study) * Subjects with a Body Mass Index \>/= 45 kg/m2 * Previous enrollment in this study * Participation in any clinical investigational drug study within the previous 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population | 21 to 28 days after completion of study drug therapy | Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | During treatment at day 5 +/- 1 day | Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'. |
| Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population | after 5 - 14 days of therapy | Clinical cure = resolution/improvement of clinical signs and symptoms related to the infection without wound infection requiring systemic antibiotic treatment. Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered. |
| Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | After 5 - 14 days of therapy | Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'. |
| Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | 21 - 28 days after end of therapy | Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection' - additionally, any recurrence or reinfection was treated as bacteriological failure at TOC. |
| Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | During treatment at day 5 +/- 1 day | Clinical improvement = Reduction in the severity and/or number of signs and symptoms of infection.Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered. |
| Number of Subjects Who Died Due to Intra-abdominal Infections | 21 - 28 days after end of treatment at TOC Visit | Number of subjects who had died due to intra abdominal infections by the time of TOC visit. |
| Duration of Hospitalization | From the first admission date to the discharge date (from 4 to 71 days after start of study medication) | Duration of hospitalization in the per protocol population. |
| Duration of Hospitalization Postoperatively | Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication) | Duration of hospitalization after the first surgery until discharge in the per protocol population. |
| Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s) | 21 - 28 days after end of therapy | Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC. |
Countries
Argentina, Belgium, Bulgaria, Estonia, France, Germany, Greece, Israel, Latvia, Lithuania, Romania, Russia, South Africa, Spain
Participant flow
Recruitment details
Subjects were enrolled from 02 July 2006 to 31 December 2008 at 52 centers in 14 countries: Argentina (9), Belgium (3), Bulgaria (4), Estonia (3), France (2 ), Germany (5), Greece (1), Israel (2), Latvia (6), Lithuania (4), Romania (5), Russia (3), South Africa (3), and Spain (2).
Pre-assignment details
830 subjects screened, 804 randomized. 6 not treated. Safety/Intent to treat population = 798 subjects with at least 1 dose taken and 1 observation after intake (Moxifloxacin 408; Ertapenem 390). Per protocol population = 699 subjects with no major protocol deviations that would have influenced the primary outcome (Moxifloxacin 352; Ertapenem 347).
Participants by arm
| Arm | Count |
|---|---|
| Moxifloxacin (Avelox, BAY12-8039) Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours. | 410 |
| Ertapenem Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours. | 394 |
| Total | 804 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 6 |
| Overall Study | Death | 7 | 2 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 27 | 19 |
| Overall Study | Non compliant with study medication | 0 | 3 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Moxifloxacin (Avelox, BAY12-8039) | Ertapenem | Total |
|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 18.3 | 47.0 years STANDARD_DEVIATION 18.2 | 47.4 years STANDARD_DEVIATION 18.2 |
| Sex: Female, Male Female | 156 Participants | 131 Participants | 287 Participants |
| Sex: Female, Male Male | 254 Participants | 263 Participants | 517 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 115 / 408 | 87 / 390 |
| serious Total, serious adverse events | 60 / 408 | 48 / 390 |
Outcome results
Primary
Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population
Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.
Time frame: 21 to 28 days after completion of study drug therapy
Population: The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subjects with no major protocol deviations that would have influenced the primary outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population | Clinical Cure | 315 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population | Clinical Failure | 37 participants |
| Ertapenem | Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population | Clinical Cure | 324 participants |
| Ertapenem | Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population | Clinical Failure | 23 participants |
Comparison: Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).95% CI: [-7.9, 0.4]
Secondary
Duration of Hospitalization
Duration of hospitalization in the per protocol population.
Time frame: From the first admission date to the discharge date (from 4 to 71 days after start of study medication)
Population: Numbers refer to patients in the per protocol population with known end of hospitalization date.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Duration of Hospitalization | 11.7 days | Standard Deviation 7.3 |
| Ertapenem | Duration of Hospitalization | 11.2 days | Standard Deviation 7.8 |
Secondary
Duration of Hospitalization Postoperatively
Duration of hospitalization after the first surgery until discharge in the per protocol population.
Time frame: Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)
Population: Numbers refer to patients in the per protocol population with known end of hospitalization date.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Duration of Hospitalization Postoperatively | 11.1 days | Standard Deviation 7.1 |
| Ertapenem | Duration of Hospitalization Postoperatively | 10.7 days | Standard Deviation 7.2 |
Secondary
Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)
Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'.
Time frame: After 5 - 14 days of therapy
Population: Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s). For one patient in the Moxifloxacin group, the data is missing due to missing EOT visit (not displayed in the table below).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Eradication | 5 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Persistence | 20 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Indeterminate/missing | 1 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Presumed Persistence | 13 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Presumed Eradication | 257 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Superinfections | 1 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Presumed Eradication | 247 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Indeterminate/missing | 0 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Eradication | 7 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Superinfections | 2 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Persistence | 9 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s) | Presumed Persistence | 11 participants |
Comparison: Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).95% CI: [-8.8, 1]
Secondary
Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)
Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection' - additionally, any recurrence or reinfection was treated as bacteriological failure at TOC.
Time frame: 21 - 28 days after end of therapy
Population: Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Superinfections | 0 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Presumed Persistence | 20 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Eradication | 0 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Reinfections | 0 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Presumed Eradication | 257 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Persistence | 20 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Presumed Eradication | 249 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Persistence | 9 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Superinfections | 0 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Reinfections | 0 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Presumed Persistence | 18 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s) | Eradication | 0 participants |
Comparison: Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).95% CI: [-9, 1.5]
Secondary
Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)
Bacteriological success = response classified as 'eradication' or 'presumed eradication' without occurrence of a superinfection. Bacteriological failure = response classified as 'persistence', 'presumed persistence', or 'superinfection'.
Time frame: During treatment at day 5 +/- 1 day
Population: Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | Presumed Persistence | 0 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | Presumed Eradication | 170 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | Superinfections | 0 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | Persistence | 16 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | Eradication | 5 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | Presumed Persistence | 2 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | Eradication | 5 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | Persistence | 7 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | Superinfections | 1 participants |
| Ertapenem | Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s) | Presumed Eradication | 149 participants |
Comparison: Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).95% CI: [-8.8, 1]
Secondary
Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population
Clinical cure = resolution/improvement of clinical signs and symptoms related to the infection without wound infection requiring systemic antibiotic treatment. Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.
Time frame: after 5 - 14 days of therapy
Population: Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population | Clinical Cure | 328 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population | Clinical Failure | 23 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population | Missing | 1 participants |
| Ertapenem | Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population | Clinical Cure | 330 participants |
| Ertapenem | Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population | Clinical Failure | 17 participants |
| Ertapenem | Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population | Missing | 0 participants |
Comparison: Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).95% CI: [-5, 1.9]
Secondary
Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)
Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.
Time frame: 21 - 28 days after end of therapy
Population: Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s) | Clinical Failure | 32 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s) | Clinical Cure | 265 participants |
| Ertapenem | Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s) | Clinical Failure | 22 participants |
| Ertapenem | Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s) | Clinical Cure | 254 participants |
Comparison: Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).95% CI: [-7.6, 1.9]
Secondary
Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population
Clinical improvement = Reduction in the severity and/or number of signs and symptoms of infection.Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.
Time frame: During treatment at day 5 +/- 1 day
Population: Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Missing | 142 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Clinical Failure | 0 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Clinical Improvement | 210 participants |
| Ertapenem | Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Clinical Improvement | 194 participants |
| Ertapenem | Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Clinical Failure | 2 participants |
| Ertapenem | Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population | Missing | 151 participants |
Comparison: Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).95% CI: [-0.4, 2.7]
Secondary
Number of Subjects Who Died Due to Intra-abdominal Infections
Number of subjects who had died due to intra abdominal infections by the time of TOC visit.
Time frame: 21 - 28 days after end of treatment at TOC Visit
Population: Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Who Died Due to Intra-abdominal Infections | Yes | 3 participants |
| Moxifloxacin (Avelox, BAY12-8039) | Number of Subjects Who Died Due to Intra-abdominal Infections | No | 349 participants |
| Ertapenem | Number of Subjects Who Died Due to Intra-abdominal Infections | Yes | 1 participants |
| Ertapenem | Number of Subjects Who Died Due to Intra-abdominal Infections | No | 346 participants |