Acinetobacter InfectionsPhase 4NCT05586815
Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Carbapenem-Resistant A. Baumannii Infection
A Phase 4 study testing Colistin and Minocycline in people with Acinetobacter Infections, run by Mahidol University at 1 site in Thailand.
Trial summary
Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with high lethality in hospitalised critically ill patients. It can acquire resistance to all classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may be the only therapeutic option. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Acinetobacter Infections
- What is being tested?
- Colistin and Minocycline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteThailand
- Study dates
- 10 Jan 2023to 30 Jun 2024
- Phase
- Phase 4
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and microbiological evidence of a severe infection due to multi-drug resistant A. baumannii during hospitalization
- Susceptibility of the A. baumannii isolate to colistin (MIC < or =2 mg/l).
Who cannot join
- Treatment with one of the study drugs prior to the diagnosis of A. baumannii infection more than 48 hours
- Severe liver dysfunction
- History of prior hypersensitivity to the study drugs
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Adhiratha Boonyasiri, MD, +6624192688, adhiratha.bon@mahidol.ac.th
Adhiratha Boonyasiri, MD
About this study
Official title: Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Therapy of Carbapenem-Resistant Acinetobacter Baumannii Infection
Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with high lethality in hospitalised critically ill patients. It can acquire resistance to all classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may be the only therapeutic option. The addition of minocycline to colistin has been shown to be synergistic in vitro, and may be promising in vivo, but this combination has not been limited to case report or case series in comparison with colistin alone.
Read the detailed description
The purpose of this double-blind, randomized, parallel, placebo-controlled clinical trial is to assess whether the association of colistin and minocycline reduces significantly the mortality of patients with severe MDR A. baumannii infections compared with colistin alone.
The trial will enroll 94 patients from internal medicine ward and intensive care units (ICU) of an university care hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be randomly allocated to either colistin plus placebo (control arm) or colistin plus minocycline (experimental arm).
Primary end point is overall mortality, defined as death occurring within 28 days from randomisation.
- Conditions
- Acinetobacter Infections
- Being tested
- Colistin, Minocycline, Placebo
- Keywords
- colistin, minocycline, carbapenem-resistant Acinetobacter baumannii
- Medical subject headings
- Acinetobacter Infections, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColistinDrug
Also called Sodium colistimethate
150 mg every 8 hours intravenously for at least 7 and up to a maximum of 28 days
MinocyclineDrug
Also called Mino
200 mg every 12 hours orally for at least 7 and up to a maximum of 28 days
PlaceboDrug
Capsule without active compound
| Study group | Role | What they receive |
|---|---|---|
| Colistin plus Placebo | Active comparator | Colistin alone, 150 mg every 8 hours intravenously or according to renal function, plus Placebo Receives: Drug: Colistin; Drug: Placebo |
| Colistin plus Minocycline | Experimental | Colistin, 150 mg every 8 hours intravenously or according to renal function, plus Minocycline, 200 mg every 12 hours orally Receives: Drug: Colistin; Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
The study primary outcome is patient overall mortality, defined as death occurring during hospitalisation or within 28 days from randomization.
Measured: 28 days
Secondary outcomes (3)
Microbiological eradication
Microbiological eradication is defined as the disappearance of A. baumannii in cultures from blood, bronchial aspirate, urines and drainage fluids.
Measured: 28 days
Incidence of Renal toxicity (safety)
Renal toxicity is defined as decrease of creatinine clearance below 50 ml/min or >50% reduction in the creatinine clearance relative to the baseline.
Measured: 28 days
Incidence of Hepatic toxicity (safety)
Hepatic toxicity is defined as increase of direct bilirubin above 3 mg/dl.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start10 Jan 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acinetobacter InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase 4 Randomized, Double blind, Placebo Controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adhiratha Boonyasiri, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586815
- Sponsor's protocol ID
- SI-CEU-03-2022
- Status last verified
- Jan 2023
- First submitted
- 17 Oct 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koomanachai P, Tiengrim S, Kiratisin P, Thamlikitkul V. Efficacy and safety of colistin (colistimethate sodium) for therapy of infections caused by multidrug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii in Siriraj Hospital, Bangkok, Thailand. Int J Infect Dis. 2007 Sep;11(5):402-6. doi: 10.1016/j.ijid.2006.09.011. Epub 2007 Feb 8.
PubMed 17291803Thamlikitkul V, Tiengrim S, Seenama C. Comparative in vitro activity of minocycline and selected antibiotics against carbapenem-resistant Acinetobacter baumannii from Thailand. Int J Antimicrob Agents. 2016 Jan;47(1):101-2. doi: 10.1016/j.ijantimicag.2015.11.006. Epub 2015 Dec 11. No abstract available.
PubMed 26725031
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Therapy of Carbapenem-Resistant Acinetobacter Baumannii Infection
- ClinicalTrials.gov ID
- NCT05586815
- Acronym / sponsor ID
- SI-CEU-03-2022
- Conditions
- Acinetobacter Infections
- Keywords
- colistin, minocycline, carbapenem-resistant Acinetobacter baumannii
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 19 Oct 2022 (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.
Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with high lethality in hospitalised critically ill patients. It can acquire resistance to all classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may be the only therapeutic option. The addition of minocycline to colistin has been shown to be synergistic in vitro, and may be promising in vivo, but this combination has not been limited to case report or case series in comparison with colistin alone.
Detailed description
The purpose of this double-blind, randomized, parallel, placebo-controlled clinical trial is to assess whether the association of colistin and minocycline reduces significantly the mortality of patients with severe MDR A. baumannii infections compared with colistin alone.
The trial will enroll 94 patients from internal medicine ward and intensive care units (ICU) of an university care hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be randomly allocated to either colistin plus placebo (control arm) or colistin plus minocycline (experimental arm).
Primary end point is overall mortality, defined as death occurring within 28 days from randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Phase 4 Randomized, Double blind, Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| Colistin plus Placebo | Active comparator | Drug: Colistin, Drug: PlaceboColistin alone, 150 mg every 8 hours intravenously or according to renal function, plus Placebo |
| Colistin plus Minocycline | Experimental | Drug: Colistin, Drug: MinocyclineColistin, 150 mg every 8 hours intravenously or according to renal function, plus Minocycline, 200 mg every 12 hours orally |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical and microbiological evidence of a severe infection due to multi-drug resistant A. baumannii during hospitalization
- Susceptibility of the A. baumannii isolate to colistin (MIC < or =2 mg/l).
Key exclusion criteria (4 listed)
- Treatment with one of the study drugs prior to the diagnosis of A. baumannii infection more than 48 hours
- Severe liver dysfunction
- History of prior hypersensitivity to the study drugs
- Pregnancy and lactation
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: Sodium colistimethate150 mg every 8 hours intravenously for at least 7 and up to a maximum of 28 days | Drug | Colistin plus Minocycline, Colistin plus Placebo |
| MinocyclineAlso: Mino200 mg every 12 hours orally for at least 7 and up to a maximum of 28 days | Drug | Colistin plus Minocycline |
| PlaceboCapsule without active compound | Drug | Colistin plus Placebo |
Primary outcome
All cause mortality
Time frame: 28 days
The study primary outcome is patient overall mortality, defined as death occurring during hospitalisation or within 28 days from randomization.
3 secondary outcomes
Microbiological eradication
Time frame: 28 days
Incidence of Renal toxicity (safety)
Time frame: 28 days
Incidence of Hepatic toxicity (safety)
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 17291803Koomanachai P, Tiengrim S, Kiratisin P, Thamlikitkul V. Efficacy and safety of colistin (colistimethate sodium) for therapy of infections caused by multidrug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii in Siriraj Hospital, Bangkok, Thailand. Int J Infect Dis. 2007 Sep;11(5):402-6. doi: 10.1016/j.ijid.2006.09.011. Epub 2007 Feb 8.
- Background: PubMed 26725031Thamlikitkul V, Tiengrim S, Seenama C. Comparative in vitro activity of minocycline and selected antibiotics against carbapenem-resistant Acinetobacter baumannii from Thailand. Int J Antimicrob Agents. 2016 Jan;47(1):101-2. doi: 10.1016/j.ijantimicag.2015.11.006. Epub 2015 Dec 11. No abstract available.
- 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.
Adhiratha Boonyasiri, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colistin and Minocycline in people with Acinetobacter Infections, 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 2 inclusion and 4 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 18 Jan 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Adhiratha Boonyasiri, MD (+66850632181, adhiratha.bon@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 28 days). 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 NCT05586815, which also lists 2 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 18 Jan 2023.