Trial reportPLoS neglected tropical diseases2019
Paradoxical reactions in Buruli ulcer after initiation of antibiotic therapy: Relationship to bacterial load.
Trial report in PLoS neglected tropical diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Study of the Pathogenesis and Management of M. Ulcerans Disease, Buruli Ulcer
Beta-Lactam Containing Regimen for the Shortening of Buruli Ulcer Disease Therapy: Comparison of 8 Weeks Standard Therapy (Rifampicin Plus Clarithromycin) vs. 4 Weeks Standard Plus Amoxicillin/Clavulanate Therapy [RC8 vs. RCA4]
Who cites it
25 citing papers in PubMed, 64 citations in OpenAlex.
- High-dose rifampicin and clarithromycin for 4 weeks versus standard-dose rifampicin and clarithromycin for 8 weeks to treat Buruli ulcer: An open-label, individually randomized, controlled trial in Ghana.PLoS neglected tropical diseases · 2026Trial
- Accelerating vaccine research and development for skin neglected tropical diseases: A case for leishmaniasis, leprosy, and Buruli ulcer.PLoS neglected tropical diseases · 2026Review
- Buruli ulcer.Nature reviews. Disease primers · 2025Review
- Antimicrobial resistant bacteria isolated from Buruli ulcer lesions in Ghana.PLoS neglected tropical diseases · 2025Article
- Improved protocols for isolation of Mycobacterium ulcerans from clinical samples.BMC microbiology · 2025Article
- Bacterial diversity in Buruli ulcer lesions in Ghana.Journal of clinical tuberculosis and other mycobacterial diseases · 2024Article
- Pilot use of a mycolactone-specific lateral flow assay for Buruli ulcer: A case report from Japan.Journal of clinical tuberculosis and other mycobacterial diseases · 2024Article
- Implementation of an integrated control programme for neglected tropical diseases of the skin in Ghana: The essential role of the laboratory.Journal of clinical tuberculosis and other mycobacterial diseases · 2024Article
- Clinical and microbiological predictors of healing in Buruli ulcer disease.Journal of clinical tuberculosis and other mycobacterial diseases · 2024Article
- Changes in Inflammatory Markers in Patients Treated for Buruli Ulcer and Their Ability to Predict Paradoxical Reactions.The Journal of infectious diseases · 2023Article
- Recent Advances in the Management Strategies for Buruli Ulcers.Pathogens (Basel, Switzerland) · 2023Review
- Memory B-cells are enriched in the blood of patients with acute Buruli ulcer disease: a prospective observational study.BMC infectious diseases · 2023Observational
- A human model of Buruli ulcer: The case for controlled human infection and considerations for selecting a Mycobacterium ulcerans challenge strain.PLoS neglected tropical diseases · 2023Review
- Repurposing of statins for Buruli Ulcer treatment: antimicrobial activity againstFrontiers in microbiology · 2023Article
- Vaccination inducing durable and robust antigen-specific Th1/Th17 immune responses contributes to prophylactic protection againstVirulence · 2022Article
- Article
- Protective Efficacy of BCG Vaccine againstVaccines · 2022Review
- Molecular and epidemiological characterization of recurrent Mycobacterium ulcerans infections in Benin.PLoS neglected tropical diseases · 2021Article
- Caregiver burden in Buruli ulcer disease: Evidence from Ghana.PLoS neglected tropical diseases · 2021Article
- Co-infection of HIV in patients with Buruli ulcer disease in Central Ghana.BMC infectious diseases · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 5 institutions in 2 countries.
Funding
Abstract
backgroundWe investigated the relationship between bacterial load in Buruli ulcer (BU) lesions and the development of paradoxical reaction following initiation of antibiotic treatment.
methodsThis was a longitudinal study involving BU patients from June 2013 to June 2017. Fine needle aspirates (FNA) and swab samples were obtained to establish the diagnosis of BU by PCR. Additional samples were obtained at baseline, during and after treatment (if the lesion had not healed) for microscopy, culture and combined 16S rRNA reverse transcriptase/ IS2404 qPCR assay. Patients were followed up at regular intervals until complete healing.
resultsForty-seven of 354 patients (13%) with PCR confirmed BU had a PR, occurring between 2 and 42 (median 6) weeks after treatment initiation. The bacterial load, the proportion of patients with positive M. ulcerans culture (15/34 (44%) vs 29/119 (24%), p = 0.025) and the proportion with positive microscopy results (19/31 (61%) vs 28/90 (31%), p = 0.003) before initiation of treatment were significantly higher in the PR compared to the no PR group. Plaques (OR 5.12; 95% CI 2.26-11.61; p<0.001), oedematous (OR 4.23; 95% CI 1.43-12.5; p = 0.009) and category II lesions (OR 2.26; 95% CI 1.14-4.48; p = 0.02) were strongly associated with the occurrence of PR. The median time to complete healing (28 vs 13 weeks, p <0.001) was significantly longer in the PR group.
conclusionsBuruli ulcer patients who develop PR are characterized by high bacterial load in lesion samples taken at baseline and a higher rate of positive M. ulcerans culture. Occurrence of a PR was associated with delayed healing.
trial registrationClinicalTrials.gov NCT02153034.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.