Hospital acquired bacterial pneumonia (HABP) Ventilator-associated bacterial pneumonia (VABP)
Conditions
Interventions
Experimental group:Sulbactam in combination with Ceftazidime and doxycycline Infected patients who meet the inclusion criteria will receive 4.0g ceftazidime plus 8.0g sulbactam per day by intravenous
Control group:Cefoperazone-sulbactam (2:1) in combination with doxycycline Infected patients who meet the inclusion criteria will receive Sulperazon (cefoperazone-sulbactam, 2 vs 1) 12.0g per day by i
Sponsors
Yongchuan Hospital of Chongqing medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who willingly sign the informed consent and authorize the legal representative also signing the informed consent. 2. Aged 18 to 75 years; 3. Positive culture indicating a pulmonary infection of carbapenem-resistant Ab in ICU patients with clinically documented HABP/VABP infection; 4. Patients who have been treated previously with an empiric antibiotic regiment and failed treatment, both clinically and microbiologically, are eligible for the study. Evidence for clinical failure should include at least one of the following symptoms: (1) New or worsening diagnosis of pneumonia defined as clinical signs and symptoms consistent with cough, dyspnea, shortness of breath (breathing rate >25/min), purulent sputum; (2) or new onset secretions drawn from the respiratory tract, Increased secretion or purulent change; (3) Or, hypoxemia defined by PaO2=38 degree C, or axillary temperature >=37 degree C; (2) Or, hypothermia diagnosed with one of the following: tympanic temperature 10,000 cells/mm3; (4) Or, White blood cell count 15% band forms of WBC in peripheral blood smears; 6. New or worsening infiltrate on chest X-ray obtained after other antimicrobial therapy prior to randomization; 7. The subjects did not participate in any other clinical trial within three months prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients who have a history of hypersensitivity or allergic reaction to any of the experimental agents; 2. patients who have used compound sulbactam preparation combined with doxycycline or minocycline since the onset of infection this time; 3. Patients who need to locally use in lungs or systematically other antimicrobial agents (e.g. colistin, tigecycline, carbapenems, aminoglycosides, fluoroquinolones, and rifampicin, etc.); 4. Patients with any significant history of diseases that are not suitable for the clinical trial by the investigators judgment; 5. Female patients who have a positive pregnancy test at Screening or who are breastfeeding; 6. Patients with severe renal function injury and creatinine clearance rate < 16ml/min converted by Cockcroft Gault formula; 7. Patients with severe liver function injury that, in the opinion of the investigator, are not suitable for the trial; 8. Patients with any condition or circumstance that, in the investigators judgement, would compromise the quality of the study data, such as those with an uncooperative attitude or unlikely to complete the trial; 9. Patients in other unmentioned circumstances that are inappropriate to the trial by the investigator judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with adjudicated clinical cure at Test of Cure (TOC) visit in the mITT Population; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients who meets the recovery criteria at Test-of-cure (TOC) Visit in the Modified Intent-to-treat (mITT);Percentage of patients with All-cause Mortality (ACM) at Day 28 or Significant Disease-Related Complication (SDRC) in the mITT Analysis Set;Percentage of patients with a favorable per-patient microbiologic response at TOC visit in mITT analysis set.;Percentage of patients with adjudicated clinical cure at end of treatment (EOT) in the mITT Population;1. Percentage of patients with adjudicated clinical cure at Last follow up (LFU) visit in the mITT Population;Percentage of patients with a favorable per-patient microbiologic response at EOT visit in mITT analysis set.;Percentage of patients with a favorable per-patient microbiologic response at LFU visit in mITT analysis set.;Time to Death Through Day 28 in the mITT Population;Percentage of patients with ACM at Day 14 in the mITT Population.;Percentage of patients with ACM at Day 28 in the mITT Population.;Percentage of Patients with Treatment-Emergent Adverse Events (TEAEs) in SS analysis set;The susceptibility rates of ceftazidime, sulbactam, cefoperazone, ceftazidime-sulbactam cefoperazone-sulbactam, doxycycline, colistin, tigecycline, ampicillin-sulbactam, levofloxacin and amikacin respectively to CR-Ab; | — |
Countries
China
Contacts
Public ContactChangqing Li
Xinchuangyi Pharmaceutical and Clinical Research CO.LTD
Outcome results
None listed