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NCT06798415
Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis
Phase 2 trial testing Metronidazole in Cutaneous Leishmaniasis in 40 participants. Currently enrolling.
1 May 2025
Quick facts
| Lead sponsor | Hayder Adnan Fawzi |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 10 February 2025 |
| Primary completion | 1 May 2025 |
| Estimated completion | 1 May 2025 |
| Sites | 1 location across Iraq |
Drugs / interventions tested
- Metronidazole (METRONIDAZOLE) — full drug profile →
Conditions studied
- Cutaneous Leishmaniasis — all drugs for Cutaneous Leishmaniasis →
Sponsor
Hayder Adnan Fawzi
Who can join
Adults 18 to 80, any sex, with Cutaneous Leishmaniasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Aim of the study to evaluate the effectiveness of intralesional metronidazole 0.5% solution as a local injection in treating cutaneous leishmaniasis. In an open-label single-arm clinical trial, all patients will be given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. Each lesion will be considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured. Intralesional metronidazole (5 mg/ml, 100 ml, Flagyl®, Sanofi, France) will be injected into each lesion based on its size (5 mg/cm2). The infiltration of intralesional dose will be given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment, and patients will be only asked to come for lesion assessment. A fine insulin needle will be used to infiltrate the lesion.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06798415
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Trials testing the same drug.
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Other recruiting trials for Cutaneous Leishmaniasis
Currently open trials in the same condition.
- NCT06797544 — Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis · Phase 2 · recruiting
- NCT06798402 — Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate · Phase 2 · recruiting
Other Hayder Adnan Fawzi trials
Trials by the same sponsor.
- NCT06797544 — Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06798415 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hayder Adnan Fawzi
- Last refreshed: 14 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06798415.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing