Study Summary
This trial is testing a new combination drug against a standard drug to see if it is better at treating serious infections caused by gram-negative bacteria.
Eligible Conditions
- Complicated Intra-abdominal Infection
- Hospital-Acquired Pneumonia
- Ventilator Associated Bacterial Pneumonia
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 10 Secondary · Reporting Duration: Test of Cure (TOC), Day 28 +/- 3 days
Day 1 and 4
Relationship between (as yet undetermined) biomarkers and liver transaminase elevations in response to exposure to ATM-AVI
Day 14
Proportion of subjects who died
Days 1 and 4
PK of ATM
PK of AVI
Day 1
Proportion of subjects with a favorable per subject microbiological response in the the micro ITT and ME analysis sets
Proportion of subjects with clinical cure by infection type in the ITT and CE analysis sets
Proportion of subjects with clinical cure in the ITT, micro ITT, CE and ME analysis sets
Day 28
PK/PD relationship between exposure and clinical response for ATM/AVI +/- MTZ in the popPK analysis set
Day 28
Proportion of subjects with a favorable per pathogen microbiological response in the micro ITT and ME analysis sets
Day 28
PK/PD relationship between exposure and clinical response for ATM AVI±MTZ in the popPK analysis set
Proportion of subjects with a favorable per subject microbiological response in the micro ITT and ME analysis sets.
Proportion of subjects with clinical cure by infection type in the ITT and CE analysis sets.
Proportion of subjects with clinical cure for subjects with MBL positive pathogens in the micro ITT and ME analysis sets.
Proportion of subjects with clinical cure in the m-ITT and ME analysis sets
Day 28
Proportion of subjects with clinical cure in the ITT and CE analysis sets
Day 28
Proportion of subjects with clinical cure using objective clinical measures
Day 28
PK/PD relationship between exposure and microbiological response for ATM/AVI+/-MTZ in the popPK analysis set
Day 28
Proportion of subjects with a favorable per pathogen microbiological response by pathogen resistance type in the micro ITT and ME analysis sets
Mannose Binding Lectin
Day 28
Health resource utilization in terms of duration of mechanical ventilation
Health resource utilization in terms of length of ICU stay
Health resource utilization in terms of length of hospital stay
Health resource utilization in terms of subsequent unplanned surgical intervention
Health resource utilization in terms of transfer to ICU
Health resource utilization in terms of treatment duration
Health resource utilization in terms of use of mechanical ventilation
Day 45
Description of safety in terms of adverse events
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
ATM-AVI + Metronidazole: High AVI Dose Cohort
17%Diarrhoea
11%Nausea
11%Hepatic enzyme increased
11%Abdominal pain lower
11%Oedema
11%Anaemia
6%Arterial injury
6%Acute kidney injury
6%Intra-abdominal haematoma
6%Postoperative ileus
6%Pancreatitis acute
6%Haemorrhage subcutaneous
6%Intestinal ischaemia
6%Dermatitis atopic
6%Hypertransaminasaemia
6%Vision blurred
6%Dizziness
6%Pneumonia
6%Limb injury
Trial Design
2 Treatment Groups
Meropenem ± Colistin
1 of 2
Aztreonam-Avibactam ± Metronidazole
1 of 2
Active Control
Experimental Treatment
425 Total Participants · 2 Treatment Groups
Primary Treatment: ATM-AVI · No Placebo Group · Phase 3
Aztreonam-Avibactam ± MetronidazoleExperimental Group · 2 Interventions: ATM-AVI, MTZ · Intervention Types: Drug, Drug
Meropenem ± ColistinActiveComparator Group · 2 Interventions: MER, COL · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATM-AVI
2016
Completed Phase 2
~40
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: test of cure (toc), day 28 +/- 3 days
Who is running the clinical trial?
PfizerLead Sponsor
4,308 Previous Clinical Trials
7,110,410 Total Patients Enrolled
3 Trials studying Complicated Intra-abdominal Infection
891 Patients Enrolled for Complicated Intra-abdominal Infection
Innovative Medicines Initiative (IMI) COMBACTE-CARE (EU)UNKNOWN
Biomedical Advanced Research and Development AuthorityFED
61 Previous Clinical Trials
100,410 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,280 Previous Clinical Trials
4,820,441 Total Patients Enrolled
1 Trials studying Complicated Intra-abdominal Infection
60 Patients Enrolled for Complicated Intra-abdominal Infection
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:is allowed
If you need surgery, it can be done within 24 hours of taking the first dose of the study drug or any time afterwards.
People who are enrolled in this study will have either cIAI confirmed intra-operatively or post-operatively
Patients with suspected HAP/VAP will often exhibit clinical signs and symptoms such as fever, coughing, and difficulty breathing
and over may enter
People who are 18 years old or older can enter.
The individual has been confirmed to have HAP/VAP or cIAI and requires intravenous antibiotic treatment.
results are provided at screening and every visit during the study
Symptoms developing more than 48 hours after someone is admitted to a care facility or within 7 days after they are discharged are more likely to be caused by something other than the care facility.
An infiltrate is an accumulation of fluid in the lungs
A respiratory specimen was obtained from a patient who was experiencing symptoms and then was randomly assigned to a group.
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Conditions
Cancer Related
Treatments