TerminatedPhase 3

Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates

Stopped: No patient included at target sample sizes

Thailand204 participantsStarted 2016-09

Plain-language summary

This study is planned to compare the clinical efficacy and safety of aerosolized plus intravenous colistin vs. intravenous colistin as adjunctive therapy for the treatment of ventilator-associated pneumonia (VAP) due to pandrugs-resistant (PDR) Acinetobacter baumannii in the neonates.

Who can participate

Age range

1 Day – 30 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Neonates who are admitted to the neonatal intensive care unit, Hat Yai Hospital during the study period. * Neonates who were complicated with VAP due to PDR-Acinetobacter baumannii susceptible to colistin (by minimal inhibitory concentration (MIC) \< 2 mcg/dL). Exclusion Criteria: * Neonates who have a major anomaly or chromosomal abnormality. * Neonates who receive colistin prior 7 days prior to study. * Neonates who have a significant renal dysfunction defined as a serum creatinine (SCr) \>1.5 mg/dL or a decrease in urine output to \< 1 mL/kg/h;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients With Cure

Timeframe: Through study completion, an average of 2 weeks

Number of Patients With Improved

Timeframe: Through study completion, an average of 2 weeks

Number of Patients With Failure

Timeframe: Through study completion, an average of 2 weeks

Number of Patients With Death

Timeframe: Through study completion, an average of 2 weeks

Trial details

NCT IDNCT02806141

SponsorHat Yai Medical Education Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

View on ClinicalTrials.gov More Pneumonia, Ventilator-Associated trials

Who can participate

Age range

1 Day – 30 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Patients With Cure

Timeframe: Through study completion, an average of 2 weeks

Number of Patients With Improved

Timeframe: Through study completion, an average of 2 weeks

Number of Patients With Failure

Timeframe: Through study completion, an average of 2 weeks

Number of Patients With Death

Timeframe: Through study completion, an average of 2 weeks