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NCT06809413
Clinical Study on the Early Bactericidal Activity of Sitafloxacin Against Mycobacterium Abscessus Disease
Phase 2 trial testing Sitafloxacin in Fluoroquinolone in 12 participants. Enrolling by invitation.
31 May 2025
Quick facts
| Lead sponsor | Beijing Chest Hospital |
|---|---|
| Phase | Phase 2 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 28 January 2025 |
| Primary completion | 31 May 2025 |
| Estimated completion | 31 May 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sitafloxacin (SITAFLOXACIN) — full drug profile →
Conditions studied
- Fluoroquinolone — all drugs for Fluoroquinolone →
- Mycobacterium — all drugs for Mycobacterium →
Sponsor
Beijing Chest Hospital
Who can join
Adults 18 to 65, any sex, with Fluoroquinolone or Mycobacterium. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a single-center, open-label clinical trial designed to evaluate the early bactericidal activity (EBA) of sitafloxacin against Mycobacterium abscessus disease. Patients with Mycobacterium abscessus disease were enrolled and treated with sitafloxacin monotherapy for 14 days. Colony forming units (CFU) and time to positivity (TTP) in sputum cultures were analyzed and compared. By assessing the impact of sitafloxacin monotherapy on the bacteria in the sputum of patients with Mycobacterium abscessus disease, the early bactericidal activity of sitafloxacin was evaluated, providing a basis for the selection of new drugs for the treatment of Mycobacterium abscessus disease.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06809413
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Related trials
Other trials of Sitafloxacin
Trials testing the same drug.
- NCT05454345 — Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment · Phase 3 · not yet recruiting
- NCT05400369 — A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstruc · Phase 4 · completed
Other Beijing Chest Hospital trials
Trials by the same sponsor.
- NCT07372781 — Clinical Study on the Early Bactericidal Activity of Contezolid Against Mycobacterium Abscessus Disease · Phase 2 · enrolling by invitation
- NCT07268664 — Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BLMZ Chinese Cohort · Phase 3 · not yet recruiting
- NCT06764368 — Phase II Study of Adebrelimab, Chemotherapy, and Apatinib for Advanced Pulmonary Neuroendocrine Tumors · Phase 2 · not yet recruiting
- NCT06811025 — Phase II Clinical Study of Contezolid for the Treatment of Tuberculous Meningitis · Phase 1, PHASE2 · enrolling by invitation
- NCT06811012 — Phase II Clinical Study of Contezolid for the Treatment of Bone and Joint Tuberculosis · Phase 1, PHASE2 · enrolling by invitation
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 NCT06809413 (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 Beijing Chest Hospital
- Last refreshed: 5 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/NCT06809413.
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