Buruli UlcerPhase 2/3BURULICONCT00321178
BURULICO Drug Trial Study Protocol: RCT SR8/SR4+CR4, GHANA
A Phase 2/3 study testing SR4 - switch to CR4 in people with Buruli Ulcer and Mycobacterium Ulcerans, run by University Medical Center Groningen at 2 sites in Ghana.
Trial summary
The standard for treatment Buruli ulcer disease (BUD) used to be surgery but the WHO now advises streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily) along with surgery. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Buruli Ulcer, Mycobacterium Ulcerans
- What is being tested?
- SR4 - switch to CR4
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesGhana
- Study dates
- May 2006to Feb 2009
- Phase
- Phase 2/3
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients
- At least 5 years of age
- A clinical diagnosis of early M. ulcerans disease including:
- Nodules
- Plaques and small ulcers with or without oedema and less than or equal to 10cm in maximum diameter
- Disease duration no longer than six months
- DRB-PCR positive for M. ulcerans
Who cannot join
- Treatment with macrolide or quinolone antibiotics, or antituberculous medication, or immunomodulatory drugs including corticosteroids within the previous one month.
- Current treatment with any drugs likely to interact with the study medication, e.g, anticoagulants, cyclosporin, phenytoin, oral contraceptive, and phenobarbitone.
- History of hypersensitivity to rifampicin, streptomycin and or clarithromycin.
- History or having current clinical signs of ascites, jaundice, partial or complete deafness, myasthenia gravis, renal dysfunction (known or suspected), diabetes mellitus, and immune compromise; or evidence for past or present tuberculosis.
- Pregnancy
- Inability to take oral medication or having gastrointestinal disease likely to interfere with drug absorption.
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- Excessive alcohol intake.
- Any situation or condition which may compromise ability to comply with the trial procedures.
- Lack of willingness to give informed consent (and/or assent by parent/legal representative).
Trial locations and contacts
2 sites in 1 country.
Ghana2 sites
Agogo Hospital
Agogo, Ashanti Region
Nkawie-Toaso Hospital
Nkawie, Ashanti Region
About this study
Official title: Randomised Trial for Early Lesions Caused by M. Ulcerans - Comparison Between 8 Weeks Streptomycin and Rifampicin (SR), or 4 Weeks SR Followed by 4 Weeks R Plus Clarithromycin
The standard for treatment Buruli ulcer disease (BUD) used to be surgery but the WHO now advises streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily) along with surgery. This preliminary advice was based on observations in 21 patients with pre-ulcerative lesions of BUD, who were given daily SR treatment for varying periods of time. In patients treated with SR for at least 4 weeks, M. ulcerans could no longer be cultured from excised lesions. SR has been introduced without a formal evaluation or comparison with other treatments have been conducted or published, but the impression is that this treatment is beneficial and may cure BUD without additional surgical management.
This study protocol evaluated the hypothesis that early, limited lesions of BUD(pre-ulcerative or ulcerated lesions, ≤ 10 cm maximum diameter), can be healed without recurrence using antimycobacterial drug therapy, without the need for debridement surgery.
Read more
In endemic regions in Ghana, patients will be actively recruited and followed if ≥ 5 years of age, and with early (i.e., onset < 6 months) BUD.
- consent by patients and / or care givers / legal representatives
- clinical evaluation, and by
- analysis of three 0.3 cm punch biopsies under local anaesthesia.
- disease confirmation: dry reagent-based polymerase chain reaction (DRB-PCR IS2404)
- randomization: either SR for 8 weeks, or 4 weeks of SR followed by R and clarithromycin (C)
- stratification: ulcerative or pre-ulcerative lesions.
Biopsies processed for histopathology, DRB-PCR-, microscopy, culture, genomic, and sensitivity tests. Lesions assessed regularly for progression or healing during treatment. Drug toxicity monitoring included blood cell counts, liver enzymes and renal tests; and ECG and audiographic tests.
Primary endpoint: healing without recurrence at 12 months follow-up after start of treatment Secondary endpoint: reduction in lesion surface area and/or clinically assessed improvement on completion of treatment, averting the need for debridement surgery.
Recurrences biopsied for confirmation, using PCR, histopathology, and culture. Sample size calculation: 2x74 fully evaluable patients; 80% power to detect a difference of 20 % in recurrence-free cure 12 months after start of treatment between the two groups (60 versus 80%). A Data Safety and Monitoring Board made interim analysis assessments.
Read the detailed description
Buruli ulcer disease (BUD) is caused by infection with Mycobacterium ulcerans. It usually starts as a small nodule under the skin but may progress to an ulcerative lesion; and eventually large, usually painless ulcers may develop. When it heals - with surgery or without - it may cause severe scarring resulting in disability and deformity. BUD has emerged as an important infectious disease among rural populations in West Africa. The standard treatment used to be surgical excision for all forms and stages. In 2004. The World Health Organisation advised the use of streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily) along with surgery. This preliminary advice was based on the observation in 21 patients with pre-ulcerative lesions of BUD, who were given daily SR treatment for varying periods of time. If patients had received such treatment for at least 4 weeks, M. ulcerans could not be cultured again from the lesions that were excised. The treatment has been implemented in areas with poor access to surgical facilities, in Pobe, Benin, and although no formal evaluation or comparison with other treatments have been conducted or published, the impression is that this treatment is probably beneficial and may cure BUD without the need for additional surgical management.
This study protocol was designed to evaluate the hypothesis that early, limited lesions of Buruli ulcer (M. ulcerans disease; pre-ulcerative or ulcerated lesions, less than or equal to 10 maximum diameter), can be healed without recurrence using antimycobacterial drug therapy, without the need for debridement surgery.
In endemic regions in Ghana, active case finding will be followed by accrual of patients
- 5 years of age and over, with
- limited early (i.e., onset less than 6 months) lesions of Buruli ulcer.
After appropriate consent by patients and / or their care givers or legal representatives, patients will be diagnosed both by
- clinical evaluation, and
- by analysis of three punch biopsies (0.3 cm each) under local anaesthesia.
Only patients with confirmation of M. ulcerans disease - presence of dry reagent-based polymerase chain reaction (DRB-PCR) signal with insertion sequence IS2404, were to be randomised to receive either SR for 8 weeks, or 4 weeks of SR followed by oral treatment consisting of R and clarithromycin (C), as allocated by a computer-generated program; patients will be stratified for ulcerative or pre-ulcerative lesions.
Patients who meet the clinical criteria for M ulcerans disease but are PCR negative, will be offered 8 weeks RS treatment, as is presently provisionally recommended by WHO, and will be evaluated separately, according to the protocol for patients allocated to 8 weeks RS treatment. All biopsies from lesions will be subjected to histopathology, DRB-PCR-, microscopy, culture, genomic, sensitivity tests and external quality control in laboratories in Kumasi (KNUST), Hamburg (BNITM), Munich (DITM) and Antwerp (ITM). Lesions will be assessed regularly for progression or healing during treatment. Drug toxicity will likewise be monitored: renal and audiographic tests for S and C, ECG for C, and liver enzymes for R and C, and blood cell counts for C.
The primary endpoint is healing without recurrence at 12 months follow-up after start of treatment Secondary endpoint is reduction in lesion surface area and/or clinically assessed improvement on completion of treatment, averting the need for debridement surgery.
Recurrences will be biopsied for confirmation, using PCR, histopathology, and culture. In all, 200 patients will need to be screened according to protocol, and 2x74 evaluable patients will be randomised based on a power analysis to detect a difference of 20 % in recurrence-free cure 12 months after start of treatment between the two groups (60 versus 80%). A Data Safety and Monitoring Board will make interim analyses.
- Conditions
- Buruli Ulcer, Mycobacterium Ulcerans
- Being tested
- SR4 - switch to CR4
- Keywords
- Mycobacterium ulcerans, Buruli ulcer, Ghana, randomized comparison, streptomycin, rifampicin, clarithromycin
- Medical subject headings
- Buruli Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR4 - switch to CR4Drug
Also called clarithromycin: Clacid
switch to oral treatment after 4 weeks SR 'standard' therapy
| Study group | Role | What they receive |
|---|---|---|
| SR4/CR4 | Experimental | after 4 weeks of standard treatment with streptomycin and rifampicin, patients in the experimental arm switch to oral treatment consisting of rifampicin and clarithromycin Receives: Drug: SR4 - switch to CR4 |
| SR8 | Active comparator | standard treatment consisting of 8 weeks of streptomycin and rifampicin Receives: Drug: SR4 - switch to CR4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing without recurrence and without debridement surgery at 12 months follow-up after start of treatment
Measured: 12 months follow-up after start of treatment
Secondary outcomes (3)
reduction in lesion surface area and/or clinically assessed improvement on completion of treatment, averting the need for debridement surgery
Measured: during treatment and follow-up x 12 months
adverse events
Measured: during treatment and follow-up x 12 months
functional limitations
Measured: at end of follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Buruli UlcerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Investigators
- Tjip S van der Werf, MD PhD, Principal investigator, University Medical Centre Groningen, University of Groningen, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321178
- Sponsor's protocol ID
- BURULICODRUGTRIAL
- Other IDs
- EU FP6 2003-INCO-Dev2-015476
- Acronym
- BURULICO
- Status last verified
- Apr 2010
- First submitted
- 2 May 2006
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Werf TS, Stienstra Y, Johnson RC, Phillips R, Adjei O, Fleischer B, Wansbrough-Jones MH, Johnson PD, Portaels F, van der Graaf WT, Asiedu K. Mycobacterium ulcerans disease. Bull World Health Organ. 2005 Oct;83(10):785-91. Epub 2005 Nov 10.
PubMed 16283056van der Werf TS, van der Graaf WT, Tappero JW, Asiedu K. Mycobacterium ulcerans infection. Lancet. 1999 Sep 18;354(9183):1013-8. doi: 10.1016/S0140-6736(99)01156-3.
PubMed 10501380Etuaful S, Carbonnelle B, Grosset J, Lucas S, Horsfield C, Phillips R, Evans M, Ofori-Adjei D, Klustse E, Owusu-Boateng J, Amedofu GK, Awuah P, Ampadu E, Amofah G, Asiedu K, Wansbrough-Jones M. Efficacy of the combination rifampin-streptomycin in preventing growth of Mycobacterium ulcerans in early lesions of Buruli ulcer in humans. Antimicrob Agents Chemother. 2005 Aug;49(8):3182-6. doi: 10.1128/AAC.49.8.3182-3186.2005.
PubMed 16048922Barogui YT, Klis SA, Johnson RC, Phillips RO, van der Veer E, van Diemen C, van der Werf TS, Stienstra Y. Genetic Susceptibility and Predictors of Paradoxical Reactions in Buruli Ulcer. PLoS Negl Trop Dis. 2016 Apr 20;10(4):e0004594. doi: 10.1371/journal.pntd.0004594. eCollection 2016 Apr.
PubMed 27097163Nienhuis WA, Stienstra Y, Abass KM, Tuah W, Thompson WA, Awuah PC, Awuah-Boateng NY, Adjei O, Bretzel G, Schouten JP, van der Werf TS. Paradoxical responses after start of antimicrobial treatment in Mycobacterium ulcerans infection. Clin Infect Dis. 2012 Feb 15;54(4):519-26. doi: 10.1093/cid/cir856. Epub 2011 Dec 7.
PubMed 22156855Nienhuis WA, Stienstra Y, Thompson WA, Awuah PC, Abass KM, Tuah W, Awua-Boateng NY, Ampadu EO, Siegmund V, Schouten JP, Adjei O, Bretzel G, van der Werf TS. Antimicrobial treatment for early, limited Mycobacterium ulcerans infection: a randomised controlled trial. Lancet. 2010 Feb 20;375(9715):664-72. doi: 10.1016/S0140-6736(09)61962-0. Epub 2010 Feb 3.
PubMed 20137805
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial for Early Lesions Caused by M. Ulcerans - Comparison Between 8 Weeks Streptomycin and Rifampicin (SR), or 4 Weeks SR Followed by 4 Weeks R Plus Clarithromycin
- ClinicalTrials.gov ID
- NCT00321178
- Acronym / sponsor ID
- BURULICO / BURULICODRUGTRIAL
- Conditions
- Buruli Ulcer, Mycobacterium Ulcerans
- Keywords
- Mycobacterium ulcerans, Buruli ulcer, Ghana, randomized comparison, streptomycin, rifampicin, clarithromycin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 3 May 2006 (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.
The standard for treatment Buruli ulcer disease (BUD) used to be surgery but the WHO now advises streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily) along with surgery. This preliminary advice was based on observations in 21 patients with pre-ulcerative lesions of BUD, who were given daily SR treatment for varying periods of time. In patients treated with SR for at least 4 weeks, M. ulcerans could no longer be cultured from excised lesions. SR has been introduced without a formal evaluation or comparison with other treatments have been conducted or published, but the impression is that this treatment is beneficial and may cure BUD without additional surgical management.
This study protocol evaluated the hypothesis that early, limited lesions of BUD(pre-ulcerative or ulcerated lesions, ≤ 10 cm maximum diameter), can be healed without recurrence using antimycobacterial drug therapy, without the need for debridement surgery.
In endemic regions in Ghana, patients will be actively recruited and followed if ≥ 5 years of age, and with early (i.e., onset < 6 months) BUD.
- consent by patients and / or care givers / legal representatives
- clinical evaluation, and by
- analysis of three 0.3 cm punch biopsies under local anaesthesia.
- disease confirmation: dry reagent-based polymerase chain reaction (DRB-PCR IS2404)
- randomization: either SR for 8 weeks, or 4 weeks of SR followed by R and clarithromycin (C)
- stratification: ulcerative or pre-ulcerative lesions.
Biopsies processed for histopathology, DRB-PCR-, microscopy, culture, genomic, and sensitivity tests. Lesions assessed regularly for progression or healing during treatment. Drug toxicity monitoring included blood cell counts, liver enzymes and renal tests; and ECG and audiographic tests.
Primary endpoint: healing without recurrence at 12 months follow-up after start of treatment Secondary endpoint: reduction in lesion surface area and/or clinically assessed improvement on completion of treatment, averting the need for debridement surgery.
Recurrences biopsied for confirmation, using PCR, histopathology, and culture. Sample size calculation: 2x74 fully evaluable patients; 80% power to detect a difference of 20 % in recurrence-free cure 12 months after start of treatment between the two groups (60 versus 80%). A Data Safety and Monitoring Board made interim analysis assessments.
Detailed description
Buruli ulcer disease (BUD) is caused by infection with Mycobacterium ulcerans. It usually starts as a small nodule under the skin but may progress to an ulcerative lesion; and eventually large, usually painless ulcers may develop. When it heals - with surgery or without - it may cause severe scarring resulting in disability and deformity. BUD has emerged as an important infectious disease among rural populations in West Africa. The standard treatment used to be surgical excision for all forms and stages. In 2004. The World Health Organisation advised the use of streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily) along with surgery. This preliminary advice was based on the observation in 21 patients with pre-ulcerative lesions of BUD, who were given daily SR treatment for varying periods of time. If patients had received such treatment for at least 4 weeks, M. ulcerans could not be cultured again from the lesions that were excised. The treatment has been implemented in areas with poor access to surgical facilities, in Pobe, Benin, and although no formal evaluation or comparison with other treatments have been conducted or published, the impression is that this treatment is probably beneficial and may cure BUD without the need for additional surgical management.
This study protocol was designed to evaluate the hypothesis that early, limited lesions of Buruli ulcer (M. ulcerans disease; pre-ulcerative or ulcerated lesions, less than or equal to 10 maximum diameter), can be healed without recurrence using antimycobacterial drug therapy, without the need for debridement surgery.
In endemic regions in Ghana, active case finding will be followed by accrual of patients
- 5 years of age and over, with
- limited early (i.e., onset less than 6 months) lesions of Buruli ulcer.
After appropriate consent by patients and / or their care givers or legal representatives, patients will be diagnosed both by
- clinical evaluation, and
- by analysis of three punch biopsies (0.3 cm each) under local anaesthesia.
Only patients with confirmation of M. ulcerans disease - presence of dry reagent-based polymerase chain reaction (DRB-PCR) signal with insertion sequence IS2404, were to be randomised to receive either SR for 8 weeks, or 4 weeks of SR followed by oral treatment consisting of R and clarithromycin (C), as allocated by a computer-generated program; patients will be stratified for ulcerative or pre-ulcerative lesions.
Patients who meet the clinical criteria for M ulcerans disease but are PCR negative, will be offered 8 weeks RS treatment, as is presently provisionally recommended by WHO, and will be evaluated separately, according to the protocol for patients allocated to 8 weeks RS treatment. All biopsies from lesions will be subjected to histopathology, DRB-PCR-, microscopy, culture, genomic, sensitivity tests and external quality control in laboratories in Kumasi (KNUST), Hamburg (BNITM), Munich (DITM) and Antwerp (ITM). Lesions will be assessed regularly for progression or healing during treatment. Drug toxicity will likewise be monitored: renal and audiographic tests for S and C, ECG for C, and liver enzymes for R and C, and blood cell counts for C.
The primary endpoint is healing without recurrence at 12 months follow-up after start of treatment Secondary endpoint is reduction in lesion surface area and/or clinically assessed improvement on completion of treatment, averting the need for debridement surgery.
Recurrences will be biopsied for confirmation, using PCR, histopathology, and culture. In all, 200 patients will need to be screened according to protocol, and 2x74 evaluable patients will be randomised based on a power analysis to detect a difference of 20 % in recurrence-free cure 12 months after start of treatment between the two groups (60 versus 80%). A Data Safety and Monitoring Board will make interim analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SR4/CR4 | Experimental | Drug: SR4 - switch to CR4after 4 weeks of standard treatment with streptomycin and rifampicin, patients in the experimental arm switch to oral treatment consisting of rifampicin and clarithromycin |
| SR8 | Active comparator | Drug: SR4 - switch to CR4standard treatment consisting of 8 weeks of streptomycin and rifampicin |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients
- At least 5 years of age
- A clinical diagnosis of early M. ulcerans disease including:
Key exclusion criteria (9 listed)
- Treatment with macrolide or quinolone antibiotics, or antituberculous medication, or immunomodulatory drugs including corticosteroids within the previous one month.
- Current treatment with any drugs likely to interact with the study medication, e.g, anticoagulants, cyclosporin, phenytoin, oral contraceptive, and phenobarbitone.
- History of hypersensitivity to rifampicin, streptomycin and or clarithromycin.
- History or having current clinical signs of ascites, jaundice, partial or complete deafness, myasthenia gravis, renal dysfunction (known or suspected), diabetes mellitus, and immune compromise; or evidence for past or present tuberculosis.
- Pregnancy
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 |
|---|---|---|
| SR4 - switch to CR4Also: clarithromycin: Clacidswitch to oral treatment after 4 weeks SR 'standard' therapy | Drug | SR4/CR4, SR8 |
Primary outcome
healing without recurrence and without debridement surgery at 12 months follow-up after start of treatment
Time frame: 12 months follow-up after start of treatment
3 secondary outcomes
reduction in lesion surface area and/or clinically assessed improvement on completion of treatment, averting the need for debridement surgery
Time frame: during treatment and follow-up x 12 months
adverse events
Time frame: during treatment and follow-up x 12 months
functional limitations
Time frame: at end of follow-up (12 months)
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 30 Jun 2010.
- Background: PubMed 16283056van der Werf TS, Stienstra Y, Johnson RC, Phillips R, Adjei O, Fleischer B, Wansbrough-Jones MH, Johnson PD, Portaels F, van der Graaf WT, Asiedu K. Mycobacterium ulcerans disease. Bull World Health Organ. 2005 Oct;83(10):785-91. Epub 2005 Nov 10.
- Background: PubMed 10501380van der Werf TS, van der Graaf WT, Tappero JW, Asiedu K. Mycobacterium ulcerans infection. Lancet. 1999 Sep 18;354(9183):1013-8. doi: 10.1016/S0140-6736(99)01156-3.
- Background: PubMed 16048922Etuaful S, Carbonnelle B, Grosset J, Lucas S, Horsfield C, Phillips R, Evans M, Ofori-Adjei D, Klustse E, Owusu-Boateng J, Amedofu GK, Awuah P, Ampadu E, Amofah G, Asiedu K, Wansbrough-Jones M. Efficacy of the combination rifampin-streptomycin in preventing growth of Mycobacterium ulcerans in early lesions of Buruli ulcer in humans. Antimicrob Agents Chemother. 2005 Aug;49(8):3182-6. doi: 10.1128/AAC.49.8.3182-3186.2005.
- Derived from this study: PubMed 27097163Barogui YT, Klis SA, Johnson RC, Phillips RO, van der Veer E, van Diemen C, van der Werf TS, Stienstra Y. Genetic Susceptibility and Predictors of Paradoxical Reactions in Buruli Ulcer. PLoS Negl Trop Dis. 2016 Apr 20;10(4):e0004594. doi: 10.1371/journal.pntd.0004594. eCollection 2016 Apr.
- Derived from this study: PubMed 22156855Nienhuis WA, Stienstra Y, Abass KM, Tuah W, Thompson WA, Awuah PC, Awuah-Boateng NY, Adjei O, Bretzel G, Schouten JP, van der Werf TS. Paradoxical responses after start of antimicrobial treatment in Mycobacterium ulcerans infection. Clin Infect Dis. 2012 Feb 15;54(4):519-26. doi: 10.1093/cid/cir856. Epub 2011 Dec 7.
- Derived from this study: PubMed 20137805Nienhuis WA, Stienstra Y, Thompson WA, Awuah PC, Abass KM, Tuah W, Awua-Boateng NY, Ampadu EO, Siegmund V, Schouten JP, Adjei O, Bretzel G, van der Werf TS. Antimicrobial treatment for early, limited Mycobacterium ulcerans infection: a randomised controlled trial. Lancet. 2010 Feb 20;375(9715):664-72. doi: 10.1016/S0140-6736(09)61962-0. Epub 2010 Feb 3.
- Global Buruli ulcer Initiative, World Health organisationLink provided by the sponsor.
- University Medical Centre Groningen, University of Groningen, the NetherlandsLink provided by the sponsor.
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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.
Tjip S van der Werf, MD PhD principal investigator
University Medical Centre Groningen, University of Groningen, the Netherlands
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SR4 - switch to CR4 in people with Buruli Ulcer and Mycobacterium Ulcerans, run by University Medical Center Groningen at 2 sites in Ghana.
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 7 inclusion and 9 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 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ghana. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
healing without recurrence and without debridement surgery at 12 months follow-up after start of treatment (time frame: 12 months follow-up after start of treatment). 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 NCT00321178, which also lists 6 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 30 Jun 2010.