N/A
N=107
Anaemetro I.V. Infusion 500mg Drug Use Investigation
Anaerobic Infection · Infectious Enterocolitis · Amebic Dysentery
Bottom Line
View on ClinicalTrials.gov: NCT03491228 ↗Enrolled (actual)
107
Serious AEs
10.3%
Results posted
Dec 2018
Primary outcome: Primary: Number of Participants With Adverse Drug Reaction (ADR) — 7; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Drug Reaction (ADR) |
7; 1 | — |
| SECONDARY Clinical Response Rate |
95.8 | — |
| SECONDARY Clinical Response Rates by Target Diseases |
93.8; 100.0; 100.0; 100.0 | — |
Summary
Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice
Eligibility Criteria
Inclusion Criteria
- Patients who have not used metronidazole (injection) in the past, and have been given this drug for treatment of anaerobic infection, infectious enterocolitis, or amebic dysentery. Patients who have used metronidazole (oral agent and vaginal tablet) in the past are eligible, and should not be excluded from this study.
Exclusion Criteria
- No exclusion criteria are set out in this study.
Data sourced from ClinicalTrials.gov (NCT03491228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.