Drug SafetyPhase 3NCT01297855
Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii
A Phase 3 study testing Colistin and Colistin plus Rifampicin in people with Drug Safety, run by Mahidol University at 1 site in Thailand.
Trial summary
In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin. In this study, patients with documented MDR. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drug Safety
- What is being tested?
- Colistin and Colistin plus Rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2010to Aug 2012
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- Hospitalized to Siriraj Hospital
- Infection with MDR A.baumanii or P.aeruginosa
- Nescessary for treatment with Colistin
- Patient agrees to participate by giving written informed consent.
Who cannot join
- pregnancy or lactating mother
- Colistin or Rifampicin allergy
- Active hepatic disease or abnormal liver function test
- patient who suspected infection with mycobacterium tuberculosis
- patient who can not drug by enteral feeding
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
Visanu Thamlikitkul, Professor, 662 419 7000 ext. 6626, sivth@mahidol.ac.th
Sunee Thanakhumtorn, 662 419 7000 ext. 6616, srstn@mahidol.ac.th
About this study
Official title: Randomized Controlled Trial of Colistin Versus Colistin Plus Rifampicin in MDR P.Aeruginosa and A.Baumanii
In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin.
In this study, patients with documented MDR. P.aeruginosa or A.baumanii will be allocated to receive Colistin alone and another group will receive Colistin plus Rifampicin.
- Conditions
- Drug Safety
- Being tested
- Colistin, Colistin plus Rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColistinDrug
Also called Colistate
Colistimethate Sodium dose 2.5-5mg/kg/day
Colistin plus RifampicinDrug
Also called Colistate, Rifampin
Colistin 2.5 to 5 mg/ Kg/ day Rifampin 10 mg/ Kg/ day
| Study group | Role | What they receive |
|---|---|---|
| Colistin | Active comparator | Colistate Receives: Drug: Colistin |
| Colistin plus Rifampicin | Experimental | Colistate Rifampin Receives: Drug: Colistin plus Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of subjects with cure or improvement
Cure Improvement Worse Death
Measured: up to day 28
Secondary outcomes (1)
number of subjects with eradication of causative bacteria
Eradication Persistence Superinfection
Measured: up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionMay 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Visanu Thamlikitkul, Mahidol University
- Investigators
- Sukij Piyasirisilp, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297855
- Sponsor's protocol ID
- SirirajCEU51-001
- Status last verified
- Dec 2011
- First submitted
- 20 Jul 2009
- Last updated
- 2 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Colistin Versus Colistin Plus Rifampicin in MDR P.Aeruginosa and A.Baumanii
- ClinicalTrials.gov ID
- NCT01297855
- Acronym / sponsor ID
- SirirajCEU51-001
- Conditions
- Drug Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 17 Feb 2011 (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.
In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin.
In this study, patients with documented MDR. P.aeruginosa or A.baumanii will be allocated to receive Colistin alone and another group will receive Colistin plus Rifampicin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colistin | Active comparator | Drug: ColistinColistate |
| Colistin plus Rifampicin | Experimental | Drug: Colistin plus RifampicinColistate Rifampin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age>18 years
- Hospitalized to Siriraj Hospital
- Infection with MDR A.baumanii or P.aeruginosa
- Nescessary for treatment with Colistin
- Patient agrees to participate by giving written informed consent.
Key exclusion criteria (5 listed)
- pregnancy or lactating mother
- Colistin or Rifampicin allergy
- Active hepatic disease or abnormal liver function test
- patient who suspected infection with mycobacterium tuberculosis
- patient who can not drug by enteral feeding
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 |
|---|---|---|
| ColistinAlso: ColistateColistimethate Sodium dose 2.5-5mg/kg/day | Drug | Colistin |
| Colistin plus RifampicinAlso: Colistate, RifampinColistin 2.5 to 5 mg/ Kg/ day Rifampin 10 mg/ Kg/ day | Drug | Colistin plus Rifampicin |
Primary outcome
number of subjects with cure or improvement
Time frame: up to day 28
Cure Improvement Worse Death
1 secondary outcome
number of subjects with eradication of causative bacteria
Time frame: up to day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2012.
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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.
Sukij Piyasirisilp, MD principal investigator
Siriraj Hospital
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 Colistin and Colistin plus Rifampicin in people with Drug Safety, run by Mahidol University 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jan 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Visanu Thamlikitkul, Professor (662 419 7000 ext. 6626, sivth@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of subjects with cure or improvement (time frame: up to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2012.