WHO ICTRP trial
Randomized treatment with either Colistin/Meropenem or Colistin/Placebo for…
EUCTR2017-002110-32-GR · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2017-002110-32-GR |
|---|---|
| Public title | Randomized treatment with either Colistin/Meropenem or Colistin/Placebo for extremely drug resistant Gram-negative Bacilli |
| Scientific title | DMID Protocol Number: 10-0065 OVERCOME Trial: Randomized Controlled Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli - OVERCOME |
| Primary sponsor | Regents of the University of Michigan |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Taiwan;Greece;Thailand;Israel;Bulgaria;Italy |
| Conditions | Blood stream Infection (BSI) and/or pneumonia due to extensively drug-resistant Gram-negative bacilli (XDR-GNB) including XDR-AB, CRE and XDR-PA MedDRA version: 20.0 Level: LLT Classification code 10004031 Term: Bacterial infection due to… |
| Interventions | Product Name: Meropenem Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Meropenem Other descriptive name: MEROPENEM TRIHYDRATE Concentration unit: g gram(s) Concentration type: equal Concentration number: 1… |
| Registration date | Jun 26, 2018 |
| Target size | 444 |
| Secondary IDs | 10-0065;NCT01597973;2017-002110-32-BG |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: