drugset / Trial / NCT06488794
Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia
Phase 2/3
Not yet recruiting
400 enrolled
University Hospital Fattouma Bourguiba
Aghia Sophia Children's Hospital of Athens · collabAthens General Children's Hospital "Pan. & Aglaia Kyriakou" · collabAttikon Hospital · collabBaşakşehir Çam ve Sakura Hospital, Istambul, Turquey · collabCerrahpaşa University School of Medicine, Istambul, Turquey · collabCukurova University School of Medicine, Adana, Turquey · collabGazi University School of Medicine, Ankara, Turquey · collabHadi Cheker university hospital, sfax, Tunisia · collabHôpital Mère-Enfant Abderrahim HAROUCHI University hospital ibn Rochd Casablanca, Morrocco · collabMarmara University · collabOsmangazi University School of Medicine, Eskişehir, Turkey · collabUniversity General Hospital of Heraklion · collabUniversity General hospital of Larissa, University of Thessaly, Larissa, Greece · collabthe European Investigators Research Network for Nebulised Antibiotics in Ventilator-Associated Pneumonia · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
The goal of this clinical trial is to learn if nebulized colistimethate sodium can prevent pneumonia in ventilated children. The main question it aims to answer is: • Does nebulized colistimethate sodium lower the number of times participants develop ventilation associated pneumonia? Researchers will compare nebulized colistimethate sodium to a placebo (a look-alike substance that contains no drug) to see if nebulized colistin works to prevent ventilation associated pneumonia in children. Participants will: * Take nebulized colistimethate sodium or a placebo twice a day for a maximum of 7 days. * Will be followed to check for pneumonia occurrence while they are on mechanical ventilation.
Timeline
- Start
- 2027-01-01
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Publications
- Background Zhu Y, Monsel A, Roberts JA, Pontikis K, Mimoz O, Rello J, Qu J, Rouby JJ; European Investigator Network for Nebulized Antibiotics in Ventilator-Associated Pneumonia (ENAVAP). Nebulized Colistin in Ventilator-Associated Pneumonia and Tracheobronchitis: Historical Background, Pharmacokinetics and Perspectives. Microorganisms. 2021 May 27;9(6):1154. doi: 10.3390/microorganisms9061154.
- Background Jang JY, Kwon HY, Choi EH, Lee WY, Shim H, Bae KS. Efficacy and toxicity of high-dose nebulized colistin for critically ill surgical patients with ventilator-associated pneumonia caused by multidrug-resistant Acinetobacter baumannii. J Crit Care. 2017 Aug;40:251-256. doi: 10.1016/j.jcrc.2017.04.004. Epub 2017 Apr 7.
- Background Karvouniaris M, Makris D, Zygoulis P, Triantaris A, Xitsas S, Mantzarlis K, Petinaki E, Zakynthinos E. Nebulised colistin for ventilator-associated pneumonia prevention. Eur Respir J. 2015 Dec;46(6):1732-9. doi: 10.1183/13993003.02235-2014. Epub 2015 Sep 24.
- Background Povoa FCC, Cardinal-Fernandez P, Maia IS, Reboredo MM, Pinheiro BV. Effect of antibiotics administered via the respiratory tract in the prevention of ventilator-associated pneumonia: A systematic review and meta-analysis. J Crit Care. 2018 Feb;43:240-245. doi: 10.1016/j.jcrc.2017.09.019. Epub 2017 Sep 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Colistimethate | Unknown | 100000 iu/kg | Other |
Indications
No indication recorded.