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NCT00229112
A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability, of Ertapenem Versus Piperacillin/Tazobactam in the Treatment of Diabetic Foot Infections in Adults.
Phase 3 trial testing MK0826, ertapenem sodium / Duration of Treatment - 24 weeks in Foot Infections in Diabetic Patients in 400 participants. Completed in 1 April 2004.
1 April 2004
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 1 April 2001 |
| Primary completion | 1 April 2004 |
| Estimated completion | 1 April 2004 |
Drugs / interventions tested
- MK0826, ertapenem sodium / Duration of Treatment - 24 weeks — full drug profile →
- Comparator: Piperacillin/Tazobactam / Duration of Treatment - 24 weeks — full drug profile →
Conditions studied
- Foot Infections in Diabetic Patients — all drugs for Foot Infections in Diabetic Patients →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
18 and older, any sex, with Foot Infections in Diabetic Patients. 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.
- Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.
Sponsor's own description
This study will compare the efficacy, safety and tolerability of intravenous ertapenem versus another intravenous antibiotic in the treatment of moderate to severe diabetic foot infections.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial.
Lipsky BA, Armstrong DG, Citron DM, Tice AD, et al · · 2005 · cited 161× · PMID 16291062 · DOI 10.1016/s0140-6736(05)67694-5
Verify or expand the search:
- PubMed search for NCT00229112
- 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 NCT00229112 (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 Merck Sharp & Dohme LLC
- Last refreshed: 16 February 2017
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/NCT00229112.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing