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NCT01757236: LIZ-BONE
Prospective,Randomized,Open Label,European Multicenter Study of the Efficacy of the Linezolid-rifampin Combination Versus Standard of Care in the Treatment of Gram-positive.
Phase 2 trial testing VANCOMYCIN in Hip Prosthetic Joint Infection in 100 participants. Status unknown.
1 April 2016
Quick facts
| Lead sponsor | University Hospital, Tours |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 October 2012 |
| Primary completion | 1 April 2016 |
| Estimated completion | 1 April 2016 |
| Sites | 9 locations across France, Italy, Spain |
Drugs / interventions tested
- VANCOMYCIN (vancomycin) — full drug profile →
- CEFTRIAXONE
- CLINDAMYCIN (clindamycin) — full drug profile →
- SULFAMETHOXAZOLE AND TRIMETHOPRIM (CO-TRIMOXAZOLE)
- FLUOROQUINOLONE — full drug profile →
- LINEZOLID — full drug profile →
- RIFAMPIN — full drug profile →
Conditions studied
- Hip Prosthetic Joint Infection — all drugs for Hip Prosthetic Joint Infection →
Sponsor
University Hospital, Tours
Who can join
Adults 18 to 80, any sex, with Hip Prosthetic Joint Infection. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Clinical cure rate
Time frame: 12 months after the end of treatment
Clinical cure rate in the modified intent-to-treat (mITT)population during the hospital visit. Patients will be declared cured if clinical signs of infection are normalized.
Sponsor's own description
The purpose of this study is to evaluate the efficacy of oral linezolid-rifampin combination therapy (over 4 or 6 weeks) versus the standard of care in the treatment of Gram-positive prosthetic hip joint infection with a one-stage surgical treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01757236
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01757236 (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 University Hospital, Tours
- Last refreshed: 27 May 2014
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/NCT01757236.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing