deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT01659437

WHO Drug Study for Buruli Ulcer - Comparison of SR8 and CR8

Randomized Controlled Trial Comparing Efficacy of 8 Weeks Treatment With Clarithromycin and Rifampicin Versus Streptomycin and Rifampicin for Buruli Ulcer (M. Ulcerans Infection)

Sponsor: Drugs for Neglected Diseases

Conditions Mycobacterium Ulcerans Infection
Interventions Clarithromycin Extended Release Streptomycin intramuscular injection
Updated 9 times since 2017 Last updated: Sep 24, 2019 Started: Dec 31, 2012 Primary completion: Dec 31, 2017 Completion: Jan 31, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01659437, this PHASE2/PHASE3 trial focuses on Mycobacterium Ulcerans Infection and remains completed. Sponsored by Drugs for Neglected Diseases, it has been updated 9 times since 2012, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotRecruiting~Feb 2017 – ~Nov 2017 · 9 months · monthly snapshotActive Not Recruiting~Nov 2017 – ~Jun 2018 · 7 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Oct 2019 · 16 months · monthly snapshotActive Not Recruiting~Oct 2019 – ~Jan 2021 · 15 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

9 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2/PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3 → PHASE2/PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

  5. Oct 2019 — Jan 2021 [monthly]

    Completed PHASE2_PHASE3

    Status: Active Not Recruiting → Completed

▶ Show 4 earlier versions

  1. Jun 2018 — Oct 2019 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  2. Nov 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  3. Feb 2017 — Nov 2017 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2_PHASE3

    First recorded

Dec 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Drugs for Neglected Diseases
  • Faculté de Médecine P&M Curie, Paris-6 - Site Pitié-Salpêtrière, France
  • Inserm U892/CNRS 699 bactériologie, Université CHU;Angers- IRIS France
  • Institute of Tropical Medicine, Antwerp, Belgium
  • Komfo Anokye Teaching Hospital
  • Kumasi Center for Collaborative Research into Tropical Medicine, Kumasi, Ghana
  • National Buruli ulcer Control Programme, Ghana Health Service, Accra, Ghana
  • Noguchi Memorial Institute of Medical Research, Accra, Ghana
  • Plastic Surgery and Burns Centre, Korle-Bu Teaching Hospital, Accra, Ghana
  • Program Nat de Lutte contre la Lèpre et l'UB;Ulcère de Buruli, Cotonou, Benin
  • School of Med Sciences, Kwame Nkrumah Univ of Sci & Techn, Kumasi, Ghana
  • University Medical Center Groningen
  • University of Ghana
  • University of Groningen
  • World Alliance for Wound and Lymphoedema Care, Switzerland
Data source: University Medical Center Groningen

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations