Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
Stopped early · Phase 3
Conditions studied: Serious Bacterial Infection
In brief
Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI), nosocomial pneumonia (NP) including hospital acquired pneumonia (HAP) and ventilator associated pneumonia (VAP), complicated urinary tract infections (cUTI), or bloodstream infections (BSI) due to metallo-β-lactamase (MBL)- producing Gram-negative bacteria.
Key facts
- Study ID
- NCT03580044
- Run by
- Pfizer
- People needed
- 15
- Starts
- 2020-12-25
- Expected to finish
- 2023-01-23
- Last updated by the study team
- 2024-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Banner University Medical Center Tucson — Tucson, Arizona, United States
- Hospital San Roque — Córdoba, Argentina
- The First Affiliated Hospital of Shantou University Medical College — Shantou, Guangdong, China
- Hunan Province People's Hospital — Changsha, Hunan, China
- Baotou Central Hospital — Baotou, Inner Mongolia, China
- Huashan Hospital Fudan University — Shanghai, Shanghai Municipality, China
- The First Hospital of Kunming — Kunming, Yunnan, China
- The First Hospital of Kunming — Kunming, China
- General Hospital of Athens "Evangelismos" — Athens, Greece
- General and Chest Diseases Hospital "Sotiria" — Athens, Greece
- General Hospital of Athens "Laiko", — Athens, Greece
- University General Hospital "ATTIKON", Medicine and Infectious Diseases — Athens, Greece
- University General Hospital of Heraklion — Heraklion, Crete, Greece
- University General Hospital of Larissa — Larissa, Greece
- Government medical College — Kozhikode, Kerala, India
- Deenanath Mangeshkar Hospital And Research Centre — Pune, Maharashtra, India
- S.R.Kalla Memorial Gastro & General Hospital — Jaipur, Rajasthan, India
- Apollo Hospitals Enterprise Limited — Chennai, Tamil Nadu, India
- Victoria Hospital, Bangalore Medical College and Research Institute — Bangalore, India
- Hospital Kuala Lumpur — Kuala Lumpur, Kuala Lumpur, Malaysia
- University Malaya Medical Centre — Kuala Lumpur, Malaysia
- Hospital Civil de Guadalajara "Fray Antonio Alcalde" — Guadalajara, Jalisco, Mexico
- Davao Doctors Hospital — Davao City, Philippines
- Makati Medical Center — Makati City, Philippines
- Manila Doctors Hospital — Manila, Philippines
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.