Gram-Negative Bacterial Infections

2

Review clinical trials related to Gram-Negative Bacterial Infections. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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 * 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.

Participants needed: 48
Trial details
Phase: Phase 2Age: 9-17Biological sex: AllType: InterventionalSponsor: PfizerUpdated: Jul 1, 2026Locations: 23
Eligibility criteria

Participants ≥9 months to <18 years of age at Screening; Female (post-menarchal)... [+2]

Other medical or psychiatric condition including recent (within the past year) o... [+8]

Status: Recruiting

Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV

This study is designed to evaluate the clinical and antibacterial efficacy, safety and pharmacokinetics of the drug Fluorothiazinone compared to placebo to prevent nosocomial gram-negative bacterial infections with participation of patients on mechanical ventilation. The main objectives of this study are: * Evaluation of the clinical and antibacterial efficacy of the drug Fluorothiazinone in combination with standard measures for the prevention of nosocomial infections compared to placebo in combination with standard measures for the prevention of nosocomial infections for the prevention of nosocomial infections caused by bacterial gram-negative flora in patients on mechanical ventilation. * Evaluation of the safety and tolerability of the drug Fluorothiazinone in patients on mechanical ventilation. * Evaluation of the pharmacokinetics (in whole blood) of the drug Fluorothiazinone with a single daily dose of 2400 mg/day. Researchers will compare results for the treatment and the placebo arms.

Participants needed: 234
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUpdated: Jun 24, 2025Locations: 2
Eligibility criteria

Patient's written consent to participate in the study in accordance with the cur... [+7]

The patient was not switched to ALV within 72 hours (3 days) after receiving the... [+5]