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NCT05639647 · ClinicalTrials.gov registry record · Phase 2
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
A Phase 2 study of Gram-negative Bacterial Infections, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT05639647 is a Phase 2 study of Gram-negative Bacterial Infections that is actively recruiting participants, run by Pfizer. The registered enrollment target is 48 participants, below the 430-participant average among 4 other Gram-negative Bacterial Infections trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT05639647, a Phase 2 study of Gram-negative Bacterial Infections, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants. The study is seeking participants who are: * 9 months to less than 18 years of age * Hospitalized * Suspected/known to have a gram-negative infection * Receiving intravenous (iv, given directly into a vein) antibiotics * Being treated for complicated infections of various body parts that includes the abdomen, urinary tract, blood stream, and lungs. * Participants will receive either ATM-AVI or best available therapy (BAT). * Both therapies will be given through a vein. * Participants with complicated abdominal infections will also receive iv Metronidazole (MTZ). Patients with cIAI and Cockayne Syndrome are excluded due to a risk of severe hepatotoxicity with the use of MTZ. - Participants on ATM-AVI treatment who have anaerobic infections will also receive iv MTZ at the study doctor's discretion. * The iv dose of ATM-AVI will be based on the participant's weight and kidney function. * The study doctor will determine the iv dose of BAT. * During the first 2 study days, participants on ATM-AVI therapy will have 5 blood draws in small quantities. * Starting on day 4, the study doctor will decide if participants may be switched to oral therapy. * Participants will receive a maximum of 14 days of ATM-AVI treatment. * After discharge from the hospital, 1 study visit may be required. * Depending on the participant's response, the study duration will be from 33 to 50 days. * The investigator will contact participants by phone 28 to 35 days after the last study treatment to check participants health status.
Conditions Studied
Interventions
- DRUG ATM-AVI
- DRUG BAT
Study Locations (20)
New York
- Weill Cornell Medicine-New York Presbyterian Hospital - New York
- Icahn School of Medicine at Mount Sinai - New York
- Mount Sinai Kravis Children´s Hospital - New York
- The Mount Sinai Hospital - New York
Other
- Shanghai Children's Medical Center - Shanghai
- Semmelweis Egyetem - Budapest
- Semmelweis Egyetem - Budapest
Barcelona [barcelona]
- Hospital Germans Trias i Pujol - Badalona
- Hospital Sant Joan de Déu - Esplugues de Llobregat
California
- Rady Children's Hospital - San Diego
Tennessee
- Le Bonheur Children's Hospital - Memphis
Beijing Municipality
- Beijing Children's Hospital, Capital Medical University - Beijing
Guangdong
- Guangzhou Women and Children's Medical Center - Guangzhou
Irakleío
- University General Hospital of Heraklion - Heraklion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-04-18 |
| Est. Completion | 2026-08-17 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05639647
The ClinicalTrials.gov registry entry for NCT05639647 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 430-participant average among 4 other Gram-negative Bacterial Infections trials with a reported enrollment target (89% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gram-negative Bacterial Infections appearing as the primary indexed condition, and to 2 interventions - of which ATM-AVI is the first listed.
NCT05639647 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, Other, Barcelona [barcelona].
Frequently Asked Questions
What is clinical trial NCT05639647 about?
NCT05639647 is a clinical study titled "Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections". The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants. The study is seeking participants who are: * 9 months to less than 18 years of age ...
What is the current status of trial NCT05639647?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2023-04-18. Estimated completion is 2026-08-17.
What conditions does trial NCT05639647 study?
This clinical trial studies the following conditions: Gram-negative Bacterial Infections.
What interventions are being tested in trial NCT05639647?
The interventions under investigation include: ATM-AVI (DRUG), BAT (DRUG).
Who is sponsoring clinical trial NCT05639647?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05639647 being conducted?
This trial has 20 study locations across California, New York, Tennessee, Beijing Municipality, Guangdong. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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