Drug SafetyPhase 3NCT01297894
Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii
A Phase 3 study testing colistin and colistin plus fosfomycin 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. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Safety
- What is being tested?
- colistin and colistin plus fosfomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2010to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years
- Hospitalized to Siriraj Hospital
- Infected caused by A. baumannii
- Need Colistin treatment
Who cannot join
- Pregnancy or Lactating mother
- Colistin or Fosfomycin Allergy
- Patients who have severe abnormal renal or liver function
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok, Bangkok, 10700
Dr. Visanu Thamlikitkul, Professor, 662-419-6626, sivth@mahidol.ac.th
Dr. Pornpan Koomanachai, MD, 662-419-7783, nokmed@yahoo.com
About this study
Official title: Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii
In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. baumannii In this study, we compare the clinical and microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A. baumannii infected patients
Read the detailed description
Inclusion criteria
- Age> 18 years
- Hospitalized to Siriraj Hospital
- Infected caused by A. baumannii
- Need Colistin treatment
Exclusion criteria
- Pregnancy or Lactating mother
- Colistin or Fosfomycin Allergy
- Patients who have severe abnormal renal or liver function
- Conditions
- Drug Safety
- Being tested
- colistin, colistin plus fosfomycin
- Keywords
- A. baumannii, colistin, fosfomycin
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 2.5-5mg/kg of colistin base
colistin plus fosfomycinDrug
Also called Colistate, Fosmicin
colitimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| colistin | Active comparator | Colistimethate sodium 2.5-5mg/kg iv Receives: Drug: colistin |
| colistin plus fosfomycin | Active comparator | colistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours Receives: Drug: colistin plus fosfomycin |
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 28days
Secondary outcomes (1)
number of subjects with eradication of causative bacteria
eradication persistence superinfection
Measured: up to 28days
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 completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Visanu Thamlikitkul, Mahidol University
- Investigators
- Visanu Thamlikitkul, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297894
- Sponsor's protocol ID
- Siriraj CEU53-001
- Status last verified
- Dec 2011
- First submitted
- 15 Feb 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sirijatuphat R, Thamlikitkul V. Preliminary study of colistin versus colistin plus fosfomycin for treatment of carbapenem-resistant Acinetobacter baumannii infections. Antimicrob Agents Chemother. 2014 Sep;58(9):5598-601. doi: 10.1128/AAC.02435-13. Epub 2014 Jun 30.
PubMed 24982065
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colistin Plus Fosfomycin in Multi-Drug Resistant Acinetobacter Baumannii
- ClinicalTrials.gov ID
- NCT01297894
- Acronym / sponsor ID
- Siriraj CEU53-001
- Conditions
- Drug Safety
- Keywords
- A. baumannii, colistin, fosfomycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- May 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. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. baumannii In this study, we compare the clinical and microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A. baumannii infected patients
Detailed description
Inclusion criteria
- Age> 18 years
- Hospitalized to Siriraj Hospital
- Infected caused by A. baumannii
- Need Colistin treatment
Exclusion criteria
- Pregnancy or Lactating mother
- Colistin or Fosfomycin Allergy
- Patients who have severe abnormal renal or liver function
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: colistinColistimethate sodium 2.5-5mg/kg iv |
| colistin plus fosfomycin | Active comparator | Drug: colistin plus fosfomycincolistimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age> 18 years
- Hospitalized to Siriraj Hospital
- Infected caused by A. baumannii
- Need Colistin treatment
Key exclusion criteria (3 listed)
- Pregnancy or Lactating mother
- Colistin or Fosfomycin Allergy
- Patients who have severe abnormal renal or liver function
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 2.5-5mg/kg of colistin base | Drug | colistin |
| colistin plus fosfomycinAlso: Colistate, Fosmicincolitimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours | Drug | colistin plus fosfomycin |
Primary outcome
number of subjects with cure or improvement
Time frame: up to 28days
cure improvement worse death
1 secondary outcome
number of subjects with eradication of causative bacteria
Time frame: up to 28days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
- Derived from this study: PubMed 24982065Sirijatuphat R, Thamlikitkul V. Preliminary study of colistin versus colistin plus fosfomycin for treatment of carbapenem-resistant Acinetobacter baumannii infections. Antimicrob Agents Chemother. 2014 Sep;58(9):5598-601. doi: 10.1128/AAC.02435-13. Epub 2014 Jun 30.
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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.
Visanu Thamlikitkul, 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 fosfomycin 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 4 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: status not confirmed, as of the sponsor's last update on 29 Dec 2011. 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 Dr Visanu Thamlikitkul, Professor (662-419-6626, 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 28days). 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 NCT01297894, which also lists 1 linked publication.
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 29 Dec 2011.