MelioidosisPhase 4NCT01420341
Co-trimoxazole as Maintenance Therapy for Melioidosis
A Phase 4 study testing Co-trimoxazole 12 and Co-trimoxazole 20 in people with Melioidosis, run by Khon Kaen University at 1 site in Thailand.
Trial summary
This is a randomised, open-labelled, controlled trial to compare the efficacy and effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of melioidosis. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Melioidosis
- What is being tested?
- Co-trimoxazole 12 and Co-trimoxazole 20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2011to 21 Jun 2019
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 15 years
- Culture-confirmed melioidosis
- Currently on oral co-trimoxazole for 12(+2) weeks without any clinical evidence of active melioidosis
- High likelihood of completing at least 6 months follow up
- Willingness to participate in the study and written, informed consent obtained from the patient
Who cannot join
- Pregnancy or breast feeding
- Contraindications to TMP-SMX: G6PD, severe adverse reactions grade 3-4 occurring during first 12 weeks of treatment
- Relapse melioidosis with at least 2 year symptom free period from last episode
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between 12 vs. 20 Weeks of Co-trimoxazole as Maintenance Therapy for Melioidosis
This is a randomised, open-labelled, controlled trial to compare the efficacy and effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of melioidosis. The study population includes 800 patients with culture-confirmed melioidosis whom 12 weeks of oral eradication therapy have been completed with or without intravenous intensive antibiotics. Patients will be randomised to either stop the eradication treatment or continue current oral treatment for 8 more weeks. The study aim to optimise the regimen used to treat melioidosis for better compliance and reducing unnecessary use of antibiotics.
Read the detailed description
Planed interim analysis will be conducted when the patient enrollment reaches 600 cases for evaluating safety and futility of the study.
- Conditions
- Melioidosis
- Being tested
- Co-trimoxazole 12, Co-trimoxazole 20
- Keywords
- Melioidosis, Co-trimoxazole, Relapse
- Medical subject headings
- Melioidosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-trimoxazole 12Drug
Receive treatment with co-trimoxazole for 12 weeks.
Co-trimoxazole 20Drug
Receive treatment with co-trimoxazole for 20 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Co-trimoxazole 12 | Active comparator | Receive treatment with co-trimoxazole for 12 weeks. Receives: Drug: Co-trimoxazole 12 |
| Co-trimoxazole 20 | Experimental | Receive treatment with co-trimoxazole for 20 weeks. Receives: Drug: Co-trimoxazole 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year non relapse rate
This is defined as clinical features of melioidosis after initial improvement, in association with cultures from any site positive for Burkhoderia pseudomallei. This can be any time point during or after stopping antibiotic treatment.
Measured: 1 year
Secondary outcomes (5)
Clinical Recurrence
Recurrent clinical features of melioidosis treated as such but not confirmed by positive culture.
Measured: 1 year
Treatment failure
Clinical decision to change treatment according to inadequate response to therapy.
Measured: 9 weeks
Mortality
Measured: 1 year
Adverse Drug Reactions
Adverse events that are caused by the drug including drug allergy.
Measured: 9 weeks
Drug compliance
This will be done by interviewing and pill counting.
Measured: 12 or 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startAug 2011
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
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 MelioidosisStudies 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
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siriluck Anunnatsiri, Khon Kaen University
- Investigators
- Siriluck Anunnatsiri, MD, Principal investigator, Khon Kaen Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420341
- Sponsor's protocol ID
- HE541074
- Other IDs
- project number 542040, 106698/B/14/Z
- Status last verified
- Sep 2020
- First submitted
- 18 Aug 2011
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anunnatsiri S, Chaowagul W, Teparrukkul P, Chetchotisakd P, Tanwisaid K, Khemla S, Narenpitak S, Pattarapongsin M, Kongsawasd W, Pisuttimarn P, Thipmontree W, Mootsikapun P, Chaisuksant S, Chierakul W, Day NPJ, Limmathurotsakul D. A Comparison Between 12 Versus 20 Weeks of Trimethoprim-sulfamethoxazole as Oral Eradication Treatment for Melioidosis: An Open-label, Pragmatic, Multicenter, Non-inferiority, Randomized Controlled Trial. Clin Infect Dis. 2021 Dec 6;73(11):e3627-e3633. doi: 10.1093/cid/ciaa1084.
PubMed 32725199
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between 12 vs. 20 Weeks of Co-trimoxazole as Maintenance Therapy for Melioidosis
- ClinicalTrials.gov ID
- NCT01420341
- Acronym / sponsor ID
- HE541074
- Conditions
- Melioidosis
- Keywords
- Melioidosis, Co-trimoxazole, Relapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 19 Aug 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.
This is a randomised, open-labelled, controlled trial to compare the efficacy and effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of melioidosis. The study population includes 800 patients with culture-confirmed melioidosis whom 12 weeks of oral eradication therapy have been completed with or without intravenous intensive antibiotics. Patients will be randomised to either stop the eradication treatment or continue current oral treatment for 8 more weeks. The study aim to optimise the regimen used to treat melioidosis for better compliance and reducing unnecessary use of antibiotics.
Detailed description
Planed interim analysis will be conducted when the patient enrollment reaches 600 cases for evaluating safety and futility of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-trimoxazole 12 | Active comparator | Drug: Co-trimoxazole 12Receive treatment with co-trimoxazole for 12 weeks. |
| Co-trimoxazole 20 | Experimental | Drug: Co-trimoxazole 20Receive treatment with co-trimoxazole for 20 weeks. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 15 years
- Culture-confirmed melioidosis
- Currently on oral co-trimoxazole for 12(+2) weeks without any clinical evidence of active melioidosis
- High likelihood of completing at least 6 months follow up
- Willingness to participate in the study and written, informed consent obtained from the patient
Key exclusion criteria (3 listed)
- Pregnancy or breast feeding
- Contraindications to TMP-SMX: G6PD, severe adverse reactions grade 3-4 occurring during first 12 weeks of treatment
- Relapse melioidosis with at least 2 year symptom free period from last episode
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 |
|---|---|---|
| Co-trimoxazole 12Receive treatment with co-trimoxazole for 12 weeks. | Drug | Co-trimoxazole 12 |
| Co-trimoxazole 20Receive treatment with co-trimoxazole for 20 weeks. | Drug | Co-trimoxazole 20 |
Primary outcome
1-year non relapse rate
Time frame: 1 year
This is defined as clinical features of melioidosis after initial improvement, in association with cultures from any site positive for Burkhoderia pseudomallei. This can be any time point during or after stopping antibiotic treatment.
5 secondary outcomes
Clinical Recurrence
Time frame: 1 year
Treatment failure
Time frame: 9 weeks
Mortality
Time frame: 1 year
Adverse Drug Reactions
Time frame: 9 weeks
Drug compliance
Time frame: 12 or 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 32725199Anunnatsiri S, Chaowagul W, Teparrukkul P, Chetchotisakd P, Tanwisaid K, Khemla S, Narenpitak S, Pattarapongsin M, Kongsawasd W, Pisuttimarn P, Thipmontree W, Mootsikapun P, Chaisuksant S, Chierakul W, Day NPJ, Limmathurotsakul D. A Comparison Between 12 Versus 20 Weeks of Trimethoprim-sulfamethoxazole as Oral Eradication Treatment for Melioidosis: An Open-label, Pragmatic, Multicenter, Non-inferiority, Randomized Controlled Trial. Clin Infect Dis. 2021 Dec 6;73(11):e3627-e3633. doi: 10.1093/cid/ciaa1084.
- Individual participant dataSharing planned: No
Related trials for Melioidosis
RecruitingObservational study
Environment, Pathogens, and Host Interactions in Melioidosis
Melioidosis
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
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.
Siriluck Anunnatsiri, MD principal investigator
Khon Kaen Univerisity
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 Co-trimoxazole 12 and Co-trimoxazole 20 in people with Melioidosis, run by Khon Kaen 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 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: finished, as of the sponsor's last update on 3 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1-year non relapse rate (time frame: 1 year). 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 NCT01420341, 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 3 Sep 2020.