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OpenTrials
Completed

NCT Number: NCT03491228

Anaemetro I.V. Infusion 500mg Drug Use Investigation

Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice

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Key information

Conditions

Anaerobic Infection Amebiasis Amebic Dysentery Digestive System Diseases Dysentery Dysentery, Amebic Gastroenteritis Gastrointestinal Diseases Infections Infectious Enterocolitis Intestinal Diseases Intestinal Diseases, Parasitic Parasitic Diseases Protozoan Infections

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants With Adverse Drug Reaction (ADR)

    Time frame: Maximum 8 weeks

    An adverse drug reaction (ADR) was any untoward medical occurrence attributed to ANAEMETRO Intravenous infusion in a participant who received ANAEMETRO Intravenous infusion. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to ANAEMETRO Intravenous infusion was assessed by the physician.

Secondary outcomes

  1. Clinical Response Rate

    Time frame: Maximum 8 weeks

    Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as "effective," "not effective," or "indeterminate" by the physician based on clinical symptoms.

    Clinical response rate, which was defined as the percentage of participants evaluated as "effective" over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.

  2. Clinical Response Rates by Target Diseases

    Time frame: Maximum 8 weeks

    Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as "effective," "not effective," or "indeterminate" by the physician based on clinical symptoms.

    Clinical response rate, which was defined as the percentage of participants evaluated as "effective" over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.

    Participants assessed as "effective" by the following target diseases were counted to assess whether they contribute to the clinical response: anaerobic infection, infectious enterocolitis, amebic dysentery, and the infection with both infectious enterocolitis and amebic dysentery.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

METRONIDAZOLE IV DRUG USE INVESTIGATION

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 9, 2018
Registry last updated
Dec 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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