Ventilator Associated PneumoniaPhase 2/3ColiPedNCT06488794
Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia
A Phase 2/3 study testing colistimethate sodium and 0.9% Saline in people with Ventilator Associated Pneumonia, run by University Hospital Fattouma Bourguiba.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- colistimethate sodium and 0.9% Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children older than 1 month and younger than 14 years
- Patients on invasive mechanical ventilation for more than 48 hours
- Informed parental consent
Who cannot join
- Suspected or confirmed VAP on the day of inclusion
- Indication for systemic colistin therapy before or at enrolment in the study
- Plan for extubation within the next 24H
- Known allergy to colistin
- No parental consent
- Tracheostomy
- Appearance of allergic clinical manifestations in the days of colistin nebulization
- Appearance of undesirable clinical or biological manifestations presumed attributable to nebulization with colistin
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia: The COLIPED Investigation
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 5 days.
- Will be followed to check for pneumonia occurrence while they are on mechanical ventilation.
Read the detailed description
The COLIPED investigation is made of phase I (COLIPED I), phase II (COLIPED II) and phase III (COLIPED III) trials. COLIPED I is a monocenter prospective observational study aimed at assessing the clinical tolerance of nebulised CMS administered over 3 days at high doses to infants and children less than 14-year old. COLIPED II and III are double-blind, multicenter randomised controlled trials. Patients on mechanical ventilation for more than 2 days will be randomized to receive inhaled colistimethate sodium twice daily for 2 to 5 days or inhaled placebo (0.9% Sodium Chloride). Primary outcome will be the occurrence of ventilator-associated pneumonia from randomization to day 28. COLIPED II will be conducted in PICUs with VAP prevalance greater than 20%, COLIPED III will be conducted in PICUs with VAP prevalence ranging between 10 to 20%
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- colistimethate sodium, 0.9% Saline
- Keywords
- colistin, mechanical ventilation, pneumonia, nebulization, prevention, pediatrics
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colistimethate sodiumDrug
Also called Colistin
100 000 IU/kg of colistimethate sodium (equivalent to 0.96 mg/kg of colistin base) , will be nebulized daily, divided into two doses for a maximum of 5 days for eligible ventilated children starting from day 3 of mechanical ventilation.
0.9% SalineDrug
Also called normal saline
Nebulization of 6 ml of 0.9% saline twice a day for a maximum of 5 days from day 3 of invasive mechanical ventilation for eligibile ventilated children
| Study group | Role | What they receive |
|---|---|---|
| colistin group | Active comparator | Colistin group:
In the Nebulized colistimethate sodium (CMS) group, 100 000 IU/kg of CMS (equivalent to 0.96 mg/kg of colistin base), will be nebulized daily, divided into two doses. The lyophilisate of CMS will be reconstituted as follows: 2 million of IU is reconstituted in 6mL of sterile 0.9% saline. The adequate volume is then withdrawn and compleated by 0.9% saline to reach a total volume of 6 ml that is administered immediately to mechanically ventilated patients via a nebulizer until the nebulized solution container becomes empty.
The nebulization is administered from day 3 of invasive mechanical ventilation, twice daily for a maximum of 5 days or until extubation (whichever occurres first).
*12500 International Units of colistimethate sodium = 1 mg colistimethate sodium = 0.4 mg of colistin base. Receives: Drug: colistimethate sodium |
| Control group | Placebo comparator | Nebulization of 6 ml of 0.9% saline twice a day for a maximum of 5 days from day 3 of invasive mechanical ventilation will be administered via a nebulizer until the nebulized solution container becomes empty. Receives: Drug: 0.9% Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ventilation Associated Pneumonia
Primary outcome will be the incidence of a first episode of ventilation associated pneumonia from randomization to day 28. Incidence will be calculated as the ratio of the number of patients experiencing a first VAP episode divided by the number of randomized patients
Measured: From randomization to 28 days post-randomization
Secondary outcomes (7)
Incidence of Ventilation Associated Tracheobronchitis
Incidence of first episode of ventilation associated tracheobronchitis (VAT) from randomization to day 28.
Measured: From randomization to 28 days post-randomization
Incidence of a first episode of VAP and VAT in the subgroup of patients with tracheobronchial bacterial colonization at randomization
This secondary outcome measures the incidence of the first episode of ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT) within the first 28 days post-randomization in patients who had tracheobronchial bacterial colonization at the time of randomization. The 28-day period is selected to capture early occurrences of these infections and to evaluate the effectiveness of preemptive colistin nebulization in this high-risk subgroup.
Measured: From randomization to 28 days post-randomization
Number of days spent on mechanical ventilation from randomization to day 28
This secondary outcome measures the total number of days a patient remains on mechanical ventilation within the first 28 days following randomization. The 28-day period is chosen to assess the impact of preemptive colistin nebulization on reducing the duration of mechanical ventilation during the critical initial phase of ICU treatment.
Measured: From randomization to 28 days post-randomization
Number of days without systemic antibiotics from randomization to day 28
This secondary outcome measures the number of days without systemic antibiotic use within the first 28 days after randomization. The 28-day period is chosen to assess the impact of preemptive colistin nebulization on reducing the requirement for systemic antibiotics during the initial critical period of ICU treatment
Measured: From randomization to 28 days post-randomization
ICU stay
Number of days spent in the ICU after randomization. This secondary outcome measures the length of stay in the ICU, defined as the number of days from randomization to ICU discharge. The time frame is chosen to comprehensively assess the duration of ICU treatment, which may be affected by the incidence of ventilator-associated pneumonia (VAP) and the impact of preemptive colistin nebulization on patient recovery
Measured: From randomization to ICU discharge, up to 60 days
Incidence of antibiotic-resistant bacteria
This secondary outcome measures the incidence of antibiotic-resistant bacteria isolated from routine clinical and hygiene samples collected from the date of randomization until ICU discharge. The time frame is chosen to monitor the development and prevalence of antibiotic-resistant bacteria throughout the entire ICU stay, providing insights into the impact of preemptive colistin nebulization on bacterial resistance patterns.
Measured: From randomization to ICU discharge
ICU day-28 mortality
This secondary outcome measures the mortality rate within 28 days of ICU admission. The time frame of 28 days is selected to assess early mortality outcomes related to ventilator-associated pneumonia and to evaluate the potential impact of preemptive colistin nebulization on patient survival during the initial critical period.
Measured: 28 days from ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Fattouma Bourguiba
- Sponsor type
- University, hospital or other
- Collaborators
- the European Investigators Research Network for Nebulised Antibiotics in Ventilator-Associated Pneumonia, University General hospital of Larissa, University of Thessaly, Larissa, Greece, Cukurova University School of Medicine, Adana, Turquey, University General Hospital of Heraklion, Osmangazi University School of Medicine, Eskişehir, Turkey, Aghia Sophia Children's Hospital of Athens, Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Attikon Hospital, Gazi University, Cerrahpaşa University School of Medicine, Istambul, Turquey, Marmara University, Başakşehir Çam ve Sakura Hospital, Istambul, Turquey, Hôpital Mère-Enfant Abderrahim HAROUCHI University hospital ibn Rochd Casablanca, Morrocco, Hadi Cheker university hospital, sfax, Tunisia, Research Laboratory LR12SP17
- Responsible party
- Principal investigator, Farah Thabet, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488794
- Sponsor's protocol ID
- FThabet
- Acronym
- ColiPed
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
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.
PubMed 34072189Jang 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.
PubMed 28458172Karvouniaris 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.
PubMed 26405294Povoa 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.
PubMed 28942198
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia: The COLIPED Investigation
- ClinicalTrials.gov ID
- NCT06488794
- Acronym / sponsor ID
- ColiPed / FThabet
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- colistin, mechanical ventilation, pneumonia, nebulization, prevention, pediatrics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital Fattouma BourguibaUniversity, hospital or other
- Collaborators
- the European Investigators Research Network for Nebulised Antibiotics in Ventilator-Associated Pneumonia, University General hospital of Larissa, University of Thessaly, Larissa, Greece, Cukurova University School of Medicine, Adana, Turquey, University General Hospital of Heraklion, Osmangazi University School of Medicine, Eskişehir, Turkey, Aghia Sophia Children's Hospital of Athens, Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Attikon Hospital, Gazi University, Cerrahpaşa University School of Medicine, Istambul, Turquey, Marmara University, Başakşehir Çam ve Sakura Hospital, Istambul, Turquey, Hôpital Mère-Enfant Abderrahim HAROUCHI University hospital ibn Rochd Casablanca, Morrocco, Hadi Cheker university hospital, sfax, Tunisia, Research Laboratory LR12SP17
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 5 days.
- Will be followed to check for pneumonia occurrence while they are on mechanical ventilation.
Detailed description
The COLIPED investigation is made of phase I (COLIPED I), phase II (COLIPED II) and phase III (COLIPED III) trials. COLIPED I is a monocenter prospective observational study aimed at assessing the clinical tolerance of nebulised CMS administered over 3 days at high doses to infants and children less than 14-year old. COLIPED II and III are double-blind, multicenter randomised controlled trials. Patients on mechanical ventilation for more than 2 days will be randomized to receive inhaled colistimethate sodium twice daily for 2 to 5 days or inhaled placebo (0.9% Sodium Chloride). Primary outcome will be the occurrence of ventilator-associated pneumonia from randomization to day 28. COLIPED II will be conducted in PICUs with VAP prevalance greater than 20%, COLIPED III will be conducted in PICUs with VAP prevalence ranging between 10 to 20%
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colistin group | Active comparator | Drug: colistimethate sodiumColistin group: In the Nebulized colistimethate sodium (CMS) group, 100 000 IU/kg of CMS (equivalent to 0.96 mg/kg of colistin base), will be nebulized daily, divided into two doses. The lyophilisate of CMS will be reconstituted as follows: 2 million of IU is reconstituted in 6mL of sterile 0.9% saline. The adequate volume is then withdrawn and compleated by 0.9% saline to reach a total volume of 6 ml that is administered immediately to mechanically ventilated patients via a nebulizer until the nebulized solution container becomes empty. The nebulization is administered from day 3 of invasive mechanical ventilation, twice daily for a maximum of 5 days or until extubation (whichever occurres first). *12500 International Units of colistimethate sodium = 1 mg colistimethate sodium = 0.4 mg of colistin base. |
| Control group | Placebo comparator | Drug: 0.9% SalineNebulization of 6 ml of 0.9% saline twice a day for a maximum of 5 days from day 3 of invasive mechanical ventilation will be administered via a nebulizer until the nebulized solution container becomes empty. |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children older than 1 month and younger than 14 years
- Patients on invasive mechanical ventilation for more than 48 hours
- Informed parental consent
Key exclusion criteria (8 listed)
- Suspected or confirmed VAP on the day of inclusion
- Indication for systemic colistin therapy before or at enrolment in the study
- Plan for extubation within the next 24H
- Known allergy to colistin
- No parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colistimethate sodiumAlso: Colistin100 000 IU/kg of colistimethate sodium (equivalent to 0.96 mg/kg of colistin base) , will be nebulized daily, divided into two doses for a maximum of 5 days for eligible ventilated children starting from day 3 of mechanical ventilation. | Drug | colistin group |
| 0.9% SalineAlso: normal salineNebulization of 6 ml of 0.9% saline twice a day for a maximum of 5 days from day 3 of invasive mechanical ventilation for eligibile ventilated children | Drug | Control group |
Primary outcome
Incidence of Ventilation Associated Pneumonia
Time frame: From randomization to 28 days post-randomization
Primary outcome will be the incidence of a first episode of ventilation associated pneumonia from randomization to day 28. Incidence will be calculated as the ratio of the number of patients experiencing a first VAP episode divided by the number of randomized patients
7 secondary outcomes
Incidence of Ventilation Associated Tracheobronchitis
Time frame: From randomization to 28 days post-randomization
Incidence of a first episode of VAP and VAT in the subgroup of patients with tracheobronchial bacterial colonization at randomization
Time frame: From randomization to 28 days post-randomization
Number of days spent on mechanical ventilation from randomization to day 28
Time frame: From randomization to 28 days post-randomization
Number of days without systemic antibiotics from randomization to day 28
Time frame: From randomization to 28 days post-randomization
ICU stay
Time frame: From randomization to ICU discharge, up to 60 days
Incidence of antibiotic-resistant bacteria
Time frame: From randomization to ICU discharge
ICU day-28 mortality
Time frame: 28 days from ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 34072189Zhu 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: PubMed 28458172Jang 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: PubMed 26405294Karvouniaris 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: PubMed 28942198Povoa 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.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing colistimethate sodium and 0.9% Saline in people with Ventilator Associated Pneumonia, run by University Hospital Fattouma Bourguiba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farah C Thabet, MD (0021629742011, thabetfarah@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Ventilation Associated Pneumonia (time frame: From randomization to 28 days post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06488794, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.