Health Condition 1: null- Treatment of Complicated Intra-Abdominal Infections
Conditions
Interventions
Intervention1: Ceftazidime-Avibactam + Metronidazole: Ceftazidime 2000 mg and 500 mg of avibactam + 500 mg of Metronidazole.
Orally.
Daily.
Arm: 1
Each patient will be on drug therapy for minimum 5 da
Sponsors
AstraZeneca AB
PPD Pharmaceutical Development India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The study should be conducted in patients aged more or equal 18 and equal or less than 65 years if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 1 week after. Intraoperative/postoperative enrollment with confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis. Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections. In India, upper age limit is less than equal to 65.
Exclusion criteria
Exclusion criteria: Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious. Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation. Patient has evidence of sepsis with shock not responding to IV fluid challenge or anticipated to require the administration of vasopressors for more than 12 hours. Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Cure as Measured by proportion of patients meeting cure criteria in the microbiological modified Intent-To-Treat analysis set.Timepoint: 28 to 35 days after start of study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: maximum concentration (Cmax), minimum concentration, area under the plasma concentration time curve at steady state, and terminal half-lifeTimepoint: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug;The favorable per-pathogen microbiologic response by minimum inhibitory concentration (MIC) categories in the microbiological modified intent to treat and microbiologically evaluable analysis setsTimepoint: within 24 hours after last dose of study drug, 28 to 35 days after start of study drug and 42 to 49 days after start of study drug;The favorable per-patient clinical response and favorable per-patient microbiological response for patients infected with ceftazidime-resistant pathogens in the microbiological modified intent to treat and microbiologically evaluable analysis sets.Timepoint: 28 to 35 days after start of study drug;The proportion of favorable per-pathogen microbiological response in the microbiological modified intent to treat and microbiologically evaluable analysis sets.Timepoint: within 24 hours after last dose of study drug, 28 to 35 days after start of study drug and 42 to 49 days after start of study drug;The proportion of patients with a favorable per-pathogen microbiological response for patients infected with ceftazidime-resistant pathogens in the microbiological modified intent to treat and microbiologically evaluable analysis setsTimepoint: 28 to 35 days after start of study drug;The proportion of patients with a favorable per-patient microbiological response in the microbiological modified intent to treat and microbiologically evaluable analysis sets.Timepoint: within 24 hours after last dose of study drug, 28 to 35 days after start of study drug and 42 to 49 days after start of study drug.;The proportion of patients with clinical cure in the clinically evaluable analysis set.Timepoi | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Greece, India, Israel, Italy, Romania, Russian Federation, Spain, Thailand, Turkey, Ukraine, United States of America
Contacts
Public ContactArun Sundriyal
PPD Pharmaceutical Development India Pvt. Ltd.
Outcome results
None listed