Infection Due to Carbapenem Resistant AcinetobacterPhase 4NCT06570850
Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection
A Phase 4 study testing Colistin Sodium Methanesulfonate and Colistin Sodium Methanesulfonate plus Fosfomycin in people with Infection Due to Carbapenem Resistant Acinetobacter, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of colistin compared with colistin plus fosfomycin against carbapenem-resistant Acinetobacter baumanii infection in Thailand. The main questions it aims to answer the following main questions: 1. Which group has better clinical response at end of treatment 2. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Infection Due to Carbapenem Resistant Acinetobacter
- What is being tested?
- Colistin Sodium Methanesulfonate and Colistin Sodium Methanesulfonate plus Fosfomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2023to Jul 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 20 years old patients who have CRAB infections (pneumonia, urinary tract infection, skin and soft tissue infection, bloodstream infection)
- Able to provide informed consent or having a legal proxy who can provide informed consent in case the subject is unable to provide consent on his own
Who cannot join
- Minimum inhibitory concentration (MIC) of colistin > 2 mg/L
- Complicated infection with inadequate source controlled
- Intracranial infection
- Infective endocarditis
- Intraabdominal infection
- Bone and joint infection
Show all 13Show fewer
- Allergic to or have contraindication(s) to any treatment regimen in the study
- Polymicrobial infection with Carbapenem-resistant Psuedomonas aeruginosa, Carbapenem-resistant Enterobacterales (CRE), Vancomycin-resistant Enterococcus (VRE)
- Pregnancy
- Previous treatment with colistin or fosfomycin more than 96 hours
- Life expectancy of 24 hour or less
- Refusal to participate in the study
- Hospice treatment
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of medicine, Chiang Mai university
Chiang Mai, 50200
Athitaya Luangnara, 0954970567, fenejung2@gmail.com
Parichat Salee, 0817830755, parichat.pimsarn@gmail.com
About this study
Official title: Efficacy of Colistin Monotherapy Versus Colistin Combined With Fosfomycin Against Carbapenem-Resistant Acinetobacter Baumannii Infections
The goal of this clinical trial is to evaluate the efficacy of colistin compared with colistin plus fosfomycin against carbapenem-resistant Acinetobacter baumanii infection in Thailand. The main questions it aims to answer the following main questions:
- Which group has better clinical response at end of treatment
- Which group has better clinical response at 72 hours and micrological cure at 72 hours and at end of treatment
Read the detailed description
Participants will be randomized in a 1:1 ratio to receive a combination of intravenous colistin plus intravenous fosfomycin (combination group) or colistin alone (monotherapy group) to determine if monotherapy or combination therapy has a better outcome.
- Being tested
- Colistin Sodium Methanesulfonate, Colistin Sodium Methanesulfonate plus Fosfomycin
- Keywords
- carbapenem resistant Acinetobacter baumanni, CRAB, Colistin, Fosfomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colistin Sodium MethanesulfonateDrug
Also called Colistin
Intravenous colistin (colistinmethate soidum) 5 mg/kg/day intravenous (dosage will be adjusted according to creatinine clearance). The duration of treatment ranges from 10 to 14 days, depending on the site of infection and clinical responsiveness.
Colistin Sodium Methanesulfonate plus FosfomycinDrug
Also called Colistin plus fosfomycin
Intravenous colistin(dosage is same as colistin group) plus intravenous fosfomycin(dosage will be adjusted according to MIC and creatinine clearance). The duration of treatment ranges from 10 to 14 days, depending on the site of infection and clinical responsiveness.
| Study group | Role | What they receive |
|---|---|---|
| Colistin group | Active comparator | Participants receive intravenous colistin (colistinmethate soidum) 5 mg/kg/day (dosage will be adjusted according to creatinine clearance) and colistin nebulization at 80 mg every 8 hours in case of pneumonia. Receives: Drug: Colistin Sodium Methanesulfonate |
| Colistin plus fosfomycin group | Active comparator | Participants receive intravenous colistin (colistinmethate soidum) (dosage regimen same as colistin group plus intravenous fosfomycin (dosage will be adjusted according to creatinine clearance and MIC). Receives: Drug: Colistin Sodium Methanesulfonate plus Fosfomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinical response after completion of therapy
Clinical response are categorized as: clinical cure if participants recover all symptoms and signs of infection; partial response if they disappear only some of the initial symptoms and signs of infection, including the condition not fulfilling all the requirements for clinical cure; and clinical failure if participants have persistence or worsening of all symptoms and signs of infection despite antimicrobial treatment.
Measured: Baseline, day 10-14 (end of therapy)
Secondary outcomes (3)
Number of participants with clinical response at 72 hours of therapy
Clinical response are categorized as: clinical cure if participants recover all symptoms and signs of infection; partial response if they disappear only some of the initial symptoms and signs of infection, including the condition not fulfilling all the requirements for clinical cure; and clinical failure if participants have persistence or worsening of all symptoms and signs of infection despite antimicrobial treatment.
Measured: Baseline, day 3
Number of participants with microbiological cure at 72 hours of therapy
Microbiological cure: no isolation of the causative agent in the infective site at 72 hours and end of treatment Microbiological failure: persistence of the causative agent in the infective site at 72 hours
Measured: Baseline, day 3
Number of participants with microbiological cure after completion of therapy
Microbiological cure: no isolation of the causative agent in the infective site at 72 hours and end of treatment Microbiological failure: persistence of the causative agent in the infective site at 72 hours
Measured: Baseline, day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Apr 2023
- Primary completionMar 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Due to Carbapenem Resistant AcinetobacterStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parichat Salee, Chiang Mai University
- Investigators
- Athitaya Luangnara, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570850
- Sponsor's protocol ID
- MED-2566-09378
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Colistin Monotherapy Versus Colistin Combined With Fosfomycin Against Carbapenem-Resistant Acinetobacter Baumannii Infections
- ClinicalTrials.gov ID
- NCT06570850
- Acronym / sponsor ID
- MED-2566-09378
- Keywords
- carbapenem resistant Acinetobacter baumanni, CRAB, Colistin, Fosfomycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 26 Aug 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 evaluate the efficacy of colistin compared with colistin plus fosfomycin against carbapenem-resistant Acinetobacter baumanii infection in Thailand. The main questions it aims to answer the following main questions:
- Which group has better clinical response at end of treatment
- Which group has better clinical response at 72 hours and micrological cure at 72 hours and at end of treatment
Detailed description
Participants will be randomized in a 1:1 ratio to receive a combination of intravenous colistin plus intravenous fosfomycin (combination group) or colistin alone (monotherapy group) to determine if monotherapy or combination therapy has a better outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colistin group | Active comparator | Drug: Colistin Sodium MethanesulfonateParticipants receive intravenous colistin (colistinmethate soidum) 5 mg/kg/day (dosage will be adjusted according to creatinine clearance) and colistin nebulization at 80 mg every 8 hours in case of pneumonia. |
| Colistin plus fosfomycin group | Active comparator | Drug: Colistin Sodium Methanesulfonate plus FosfomycinParticipants receive intravenous colistin (colistinmethate soidum) (dosage regimen same as colistin group plus intravenous fosfomycin (dosage will be adjusted according to creatinine clearance and MIC). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 20 years old patients who have CRAB infections (pneumonia, urinary tract infection, skin and soft tissue infection, bloodstream infection)
- Able to provide informed consent or having a legal proxy who can provide informed consent in case the subject is unable to provide consent on his own
Key exclusion criteria (13 listed)
- Minimum inhibitory concentration (MIC) of colistin > 2 mg/L
- Complicated infection with inadequate source controlled
- Intracranial infection
- Infective endocarditis
- Intraabdominal infection
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 |
|---|---|---|
| Colistin Sodium MethanesulfonateAlso: ColistinIntravenous colistin (colistinmethate soidum) 5 mg/kg/day intravenous (dosage will be adjusted according to creatinine clearance). The duration of treatment ranges from 10 to 14 days, depending on the site of infection and clinical responsiveness. | Drug | Colistin group |
| Colistin Sodium Methanesulfonate plus FosfomycinAlso: Colistin plus fosfomycinIntravenous colistin(dosage is same as colistin group) plus intravenous fosfomycin(dosage will be adjusted according to MIC and creatinine clearance). The duration of treatment ranges from 10 to 14 days, depending on the site of infection and clinical responsiveness. | Drug | Colistin plus fosfomycin group |
Primary outcome
Number of participants with clinical response after completion of therapy
Time frame: Baseline, day 10-14 (end of therapy)
Clinical response are categorized as: clinical cure if participants recover all symptoms and signs of infection; partial response if they disappear only some of the initial symptoms and signs of infection, including the condition not fulfilling all the requirements for clinical cure; and clinical failure if participants have persistence or worsening of all symptoms and signs of infection despite antimicrobial treatment.
3 secondary outcomes
Number of participants with clinical response at 72 hours of therapy
Time frame: Baseline, day 3
Number of participants with microbiological cure at 72 hours of therapy
Time frame: Baseline, day 3
Number of participants with microbiological cure after completion of therapy
Time frame: Baseline, day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Infection Due to Carbapenem Resistant Acinetobacter
Not yet recruitingPhase 2
Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP)
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.
Athitaya Luangnara principal investigator
Chiang Mai 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 Sodium Methanesulfonate and Colistin Sodium Methanesulfonate plus Fosfomycin in people with Infection Due to Carbapenem Resistant Acinetobacter, run by Chiang Mai 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 13 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 26 Aug 2024. 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 Athitaya Luangnara (0954970567, fenejung2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinical response after completion of therapy (time frame: Baseline, day 10-14 (end of therapy)). 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 26 Aug 2024.