Pneumonia, Ventilator-AssociatedPhase 3NCT02806141
Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates
A Phase 3 study testing Aerosolized plus intravenous colistin and Intravenous colistin in people with Pneumonia, Ventilator-Associated and Colistin Adverse Reaction, run by Hat Yai Medical Education Center at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Pneumonia, Ventilator-Associated, Colistin Adverse Reaction, Infection Due to Multidrug Resistant Acinetobacter
- What is being tested?
- Aerosolized plus intravenous colistin and Intravenous colistin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2016to Oct 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerosolized Plus Intravenous Colistin Compared With Intravenous Colistin for Adjunctive Treatment of Ventilator-associated Pneumonia Due to Pandrugs-resistant Acinetobacter Baumannii in the Neonates: Randomized Controlled Trial
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.
Read the detailed description
This study will evaluate the neonates with VAP due to PDR-Acinetobacter baumannii who receive aerosolized plus intravenous colistin compare with intravenous colistin as adjunctive therapy. The efficacy and safety after study will be evaluated.
- Conditions
- Pneumonia, Ventilator-Associated, Colistin Adverse Reaction, Infection Due to Multidrug Resistant Acinetobacter, Infection Resistant to Multiple Drugs
- Being tested
- Aerosolized plus intravenous colistin, Intravenous colistin
- Keywords
- Aerosolized colistin, Intravenous colistin
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosolized plus intravenous colistinDrug
Also called colistimethate sodium
Aerosolized colistin at the dose of 4 mg colistin base activity (CBA)/kg twice daily (8 mg/kg/day) plus intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)
Intravenous colistinDrug
Also called colistimethate sodium
Intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)
| Study group | Role | What they receive |
|---|---|---|
| Aerosolized plus intravenous colistin | Experimental | Neonates with VAP due to PDR-A. baumannii who receive aerosolized colistin (4 mg/kg/dose twice daily) plus intravenous colistin (3.5 mg/kg/dose twice daily) Receives: Drug: Aerosolized plus intravenous colistin |
| Intravenous colistin | Active comparator | Neonates with VAP due to PDR-A. baumannii who receive only intravenous colistin (3.5 mg/kg/dose twice daily) Receives: Drug: Intravenous colistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Cure
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Measured: Through study completion, an average of 2 weeks
Number of Patients With Improved
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Measured: Through study completion, an average of 2 weeks
Number of Patients With Failure
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Measured: Through study completion, an average of 2 weeks
Number of Patients With Death
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Measured: Through study completion, an average of 2 weeks
Secondary outcomes (4)
Number of Patients With Eradication
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Measured: Through study completion, an average of 2 weeks
Number of Patients With Persistence
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Measured: Through study completion, an average of 2 weeks
Number of Patients With Superinfection
Microbiological response is classified in 3 categories: Eradication Persistence, Superinfection
Measured: Through study completion, an average of 2 weeks
Number of Patients With Adverse Events That Are Related to Study Drug
Number of Patients With Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 focus on neurology, pulmonology, nephrology and metabolic/laboratory.
Measured: Through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: No patient included at target sample sizes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Ventilator-AssociatedStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hat Yai Medical Education Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Narongsak Nakwan, Hat Yai Medical Education Center
- Investigators
- Narongsak Nakwan, MD, Principal investigator, Hat Yai Medical Education Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806141
- Sponsor's protocol ID
- HatYaiMec-Neonate
- Status last verified
- Jul 2018
- First submitted
- 8 Jun 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nakwan N, Wannaro J, Thongmak T, Pornladnum P, Saksawad R, Nakwan N, Chokephaibulkit K. Safety in treatment of ventilator-associated pneumonia due to extensive drug-resistant Acinetobacter baumannii with aerosolized colistin in neonates: a preliminary report. Pediatr Pulmonol. 2011 Jan;46(1):60-6. doi: 10.1002/ppul.21324. Epub 2010 Sep 1.
PubMed 20812247Nakwan N, Lertpichaluk P, Chokephaibulkit K, Villani P, Regazzi M, Imberti R. Pulmonary and Systemic Pharmacokinetics of Colistin Following a Single Dose of Nebulized Colistimethate in Mechanically Ventilated Neonates. Pediatr Infect Dis J. 2015 Sep;34(9):961-3. doi: 10.1097/INF.0000000000000775.
PubMed 26065861Nakwan N, Usaha S, Chokephaibulkit K, Villani P, Regazzi M, Imberti R. Pharmacokinetics of Colistin Following a Single Dose of Intravenous Colistimethate Sodium in Critically Ill Neonates. Pediatr Infect Dis J. 2016 Nov;35(11):1211-1214. doi: 10.1097/INF.0000000000001263.
PubMed 27276179
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerosolized Plus Intravenous Colistin Compared With Intravenous Colistin for Adjunctive Treatment of Ventilator-associated Pneumonia Due to Pandrugs-resistant Acinetobacter Baumannii in the Neonates: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02806141
- Acronym / sponsor ID
- HatYaiMec-Neonate
- Conditions
- Pneumonia, Ventilator-Associated, Colistin Adverse Reaction, Infection Due to Multidrug Resistant Acinetobacter, Infection Resistant to Multiple Drugs
- Keywords
- Aerosolized colistin, Intravenous colistin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No patient included at target sample sizes
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Hat Yai Medical Education CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 20 Jun 2016 (estimated)
- 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.
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.
Detailed description
This study will evaluate the neonates with VAP due to PDR-Acinetobacter baumannii who receive aerosolized plus intravenous colistin compare with intravenous colistin as adjunctive therapy. The efficacy and safety after study will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerosolized plus intravenous colistin | Experimental | Drug: Aerosolized plus intravenous colistinNeonates with VAP due to PDR-A. baumannii who receive aerosolized colistin (4 mg/kg/dose twice daily) plus intravenous colistin (3.5 mg/kg/dose twice daily) |
| Intravenous colistin | Active comparator | Drug: Intravenous colistinNeonates with VAP due to PDR-A. baumannii who receive only intravenous colistin (3.5 mg/kg/dose twice daily) |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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;
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 |
|---|---|---|
| Aerosolized plus intravenous colistinAlso: colistimethate sodiumAerosolized colistin at the dose of 4 mg colistin base activity (CBA)/kg twice daily (8 mg/kg/day) plus intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day) | Drug | Aerosolized plus intravenous colistin |
| Intravenous colistinAlso: colistimethate sodiumIntravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day) | Drug | Intravenous colistin |
Primary outcome
Number of Patients With Cure
Time frame: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Improved
Time frame: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Failure
Time frame: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Death
Time frame: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
4 secondary outcomes
Number of Patients With Eradication
Time frame: Through study completion, an average of 2 weeks
Number of Patients With Persistence
Time frame: Through study completion, an average of 2 weeks
Number of Patients With Superinfection
Time frame: Through study completion, an average of 2 weeks
Number of Patients With Adverse Events That Are Related to Study Drug
Time frame: Through study completion, an average of 4 weeks
Results and safety
The study was stopped early (reason given: No patient included at target sample sizes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Background: PubMed 20812247Nakwan N, Wannaro J, Thongmak T, Pornladnum P, Saksawad R, Nakwan N, Chokephaibulkit K. Safety in treatment of ventilator-associated pneumonia due to extensive drug-resistant Acinetobacter baumannii with aerosolized colistin in neonates: a preliminary report. Pediatr Pulmonol. 2011 Jan;46(1):60-6. doi: 10.1002/ppul.21324. Epub 2010 Sep 1.
- Background: PubMed 26065861Nakwan N, Lertpichaluk P, Chokephaibulkit K, Villani P, Regazzi M, Imberti R. Pulmonary and Systemic Pharmacokinetics of Colistin Following a Single Dose of Nebulized Colistimethate in Mechanically Ventilated Neonates. Pediatr Infect Dis J. 2015 Sep;34(9):961-3. doi: 10.1097/INF.0000000000000775.
- Background: PubMed 27276179Nakwan N, Usaha S, Chokephaibulkit K, Villani P, Regazzi M, Imberti R. Pharmacokinetics of Colistin Following a Single Dose of Intravenous Colistimethate Sodium in Critically Ill Neonates. Pediatr Infect Dis J. 2016 Nov;35(11):1211-1214. doi: 10.1097/INF.0000000000001263.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Narongsak Nakwan, MD principal investigator
Hat Yai Medical Education Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aerosolized plus intravenous colistin and Intravenous colistin in people with Pneumonia, Ventilator-Associated and Colistin Adverse Reaction, run by Hat Yai Medical Education Center at 1 site in Thailand.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study was stopped early (reason given: No patient included at target sample sizes). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Cure (time frame: Through study completion, an average of 2 weeks). The study lists 4 primary outcomes in all. 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 NCT02806141, which also lists 3 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 2 Aug 2018.