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NCT02205112
A Multi-center, Randomized, Double-Blind, Parallel Comparative, Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin Versus Levofloxain in Treating Adult Patients With CAP
Phase 3 trial testing Nemonoxacin in Community-acquired Pneumonia in 598 participants. Completed in 15 May 2017.
4 May 2017
Quick facts
| Lead sponsor | TaiGen Biotechnology Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 598 |
| Start date | 1 June 2014 |
| Primary completion | 4 May 2017 |
| Estimated completion | 15 May 2017 |
| Sites | 63 locations across China, Taiwan |
Drugs / interventions tested
- Nemonoxacin (NEMONOXACIN) — full drug profile →
- Levofloxacin (Levofloxacin) — full drug profile →
Conditions studied
- Community-acquired Pneumonia — all drugs for Community-acquired Pneumonia →
Sponsor
TaiGen Biotechnology Co., Ltd. — full company profile →
Who can join
Adults 18 to 80, any sex, with Community-acquired Pneumonia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Per subject clinical cure rate
Time frame: end of treatment and 7 to 14 days after the end of treatment
The clinical cure rate will be evaluated according to signs and symptoms and changes in the chest X-ray
Sponsor's own description
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous nemonoxacin compared with intravenous moxifloxacin in adult patients with community-acquired pneumonia (CAP).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Efficacy of Phage- and Bacteriocin-Based Therapies in Combatting Nosocomial MRSA Infections.
Walsh L, Johnson CN, Hill C, Ross RP. · · 2021 · cited 28× · PMID 33996906 · DOI 10.3389/fmolb.2021.654038 -
Pharmacotherapy of Lower Respiratory Tract Infections in Elderly-Focused on Antibiotics.
Liu Y, Zhang Y, Zhao W, Liu X, et al · · 2019 · cited 12× · PMID 31736751 · DOI 10.3389/fphar.2019.01237 -
Managing community acquired pneumonia in the elderly - the next generation of pharmacotherapy on the horizon.
Amalakuhan B, Echevarria KL, Restrepo MI. · · 2017 · cited 12× · PMID 28598693 · DOI 10.1080/14656566.2017.1340937 -
A multicentre, randomised, double-blind, double-dummy, parallel-controlled, phase 3 clinical trial assessing the efficacy and safety of intravenous nemonoxacin malate vs. levofloxacin for community-acquired pneumonia in adult patients.
Li Y, Zhu D, Sun S, Chang X, et al · · 2024 · cited 4× · PMID 38851462 · DOI 10.1016/j.ijantimicag.2024.107235
Verify or expand the search:
- PubMed search for NCT02205112
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nemonoxacin
Trials testing the same drug.
- NCT05133752 — Oral Nemonoxacin in Treating Elderly Patients With CAP · Phase 4 · completed
- NCT03551210 — Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia · Phase 3 · completed
- NCT02604498 — Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Moderate Impaired Hepatic Function · Phase 1 · completed
Other recruiting trials for Community-acquired Pneumonia
Currently open trials in the same condition.
- NCT07164131 — Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lacta · Phase 4 · recruiting
- NCT06577558 — Efficacy and Safety of SR1375 in Adult Patients With CAP · Phase 2 · recruiting
- NCT06229288 — Amoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, an · Phase 3 · recruiting
- NCT06125340 — Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Short-course Therapy · Phase 4 · recruiting
- NCT06114888 — Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: Novel Diagnostics · NA · recruiting
Other TaiGen Biotechnology Co., Ltd. trials
Trials by the same sponsor.
- NCT07415304 — A Phase 1 Study of ISM4808 in Healthy Adult Subjects · Phase 1 · not yet recruiting
- NCT04706468 — To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenz · Phase 2 · completed
- NCT04495322 — To Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of TG-1000 in Healthy Volunteers, and the Food Effec · Phase 1 · completed
- NCT05133752 — Oral Nemonoxacin in Treating Elderly Patients With CAP · Phase 4 · completed
- NCT03362853 — A Study Evaluating the Effect of a Single-dose Oral Administration of Nemonoxacin Capsule on QTc Intervals and Heart Rhy · Phase 1 · completed
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 NCT02205112 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by TaiGen Biotechnology Co., Ltd.
- Last refreshed: 22 October 2021
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/NCT02205112.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing