Clostridium Difficile, Diarrhea
Conditions
Brief summary
This is a prospective, non-comparative, interventional, observational pilot study of the safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard oral therapy in patients with known mild to severe confirmed Clostridium difficile associated diarrhea (CDAD).
Detailed description
The intervention is adding Tigecycline (standard doses) to standard oral therapy for CDAD. Patients will then be observed for clinical outcomes and relapse of CDAD.
Interventions
DRUGTigecycline
: Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 milligram loading dose followed by 50 milligrams every 12 hours) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
Sponsors
Pfizer
Gary E. Stein, Pharm.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* non pregnant adults (≥18 years old) with a diagnosis of mild to severe CDAD (initial or recurrent) by positive C. difficile toxin assay along with clinical symptoms (watery stools, fever, abdominal pain). Patients will receive a minimum of 3 days of tigecycline.
Exclusion criteria
* pregnant patients * allergy to tetracycline (or tigecycline) antibiotics or patients with life-threatening illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile | day 3 of treatment | Serum levels of tigecycline |
| Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates | day 1 stool sample | — |
| Mean (SD) Serum Tigecycline Concentration Level | day 3 of tigecycline therapy | Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay. |
| Mean (SD) Stool Tigecycline Concentration Level | day 3 of tigecycline therapy | Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay |
Countries
United States
Participant flow
Recruitment details
Subjects were inpatients (Sparrow Hospital) with Clostridium difficile who were treated with tigecycline. Referral base was infectious disease consultations. The first patient was enrolled 11-23-2011 and the last 9-13-2012.
Participants by arm
| Arm | Count |
|---|---|
| CDAD Patient Open non-comparative trial
Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | CDAD Patient | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 7 Participants | — |
| Age, Continuous | 63 years STANDARD_DEVIATION 16 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates
Time frame: day 1 stool sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clostridium Difficile Patient | Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates | 0.15 milligram/liter | Standard Deviation 0.06 |
Primary
Mean (SD) Serum Tigecycline Concentration Level
Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay.
Time frame: day 3 of tigecycline therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clostridium Difficile Patient | Mean (SD) Serum Tigecycline Concentration Level | 0.18 milligram/liter | Standard Deviation 0.14 |
Primary
Mean (SD) Stool Tigecycline Concentration Level
Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay
Time frame: day 3 of tigecycline therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clostridium Difficile Patient | Mean (SD) Stool Tigecycline Concentration Level | 17.8 micrograms/gram | Standard Deviation 23.8 |
Primary
Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile
Serum levels of tigecycline
Time frame: day 3 of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clostridium Difficile Patient | Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile | 0.18 milligrams/liter | Standard Deviation 0.14 |
Primary
Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile
Stool levels of tigecycline
Time frame: day 3 of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clostridium Difficile Patient | Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile | 17.8 micrograms/gram | Standard Deviation 23.8 |