WHO ICTRP trial
Ceftolozane/tazobactam (MK-7625A) plus Metronidazole versus Meropenem in…
EUCTR2016-004820-41-LT · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2016-004820-41-LT |
|---|---|
| Public title | Ceftolozane/tazobactam (MK-7625A) plus Metronidazole versus Meropenem in pediatric complicated intra-abdominal infection |
| Scientific title | A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem in Pediatric Subjects with Complicated Intra- Abdominal Infection - Ceftolozane/tazobactam… |
| Primary sponsor | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United States;Hungary;Mexico;Spain;Malaysia;Brazil;Ukraine;Turkey;Romania;Lithuania;South Africa;Russian Federation |
| Conditions | Complicated intra-abdominal infection (cIAI) MedDRA version: 20.1 Level: LLT Classification code 10056570 Term: Intra-abdominal infection System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses… |
| Interventions | Trade Name: Zerbaxa Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Ceftolozane CAS Number: 936111-69-2 Current Sponsor code: MK7625A Other descriptive name: CEFTOLOZANE SULFATE Concentration unit: g gram(s)… |
| Registration date | May 29, 2017 |
| Target size | 120 |
| Secondary IDs | MK-7625A-035 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: