A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of Glucose-6-dehydrogenase Status in South-east Bangladesh

PR-14053

This is a study assessing safety and efficacy of current national guidelines for the treatment of uncomplicated malaria in Bangladesh as well as to assess the G6PD status among the enrolled patients.

2014-08-01

2015-03-01

2015-03-01

Completed

Early phase I

181

Inclusion Criteria: * Age ≥ 12 months * P. vivax or P. falciparum monoinfection or P.v. / P.f. mixed infection * Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs * Ability to swallow oral medication. * Ability and willingness to comply with the study protocol for the duration of the study * Informed consent/assent from the patient or from a parent or guardian in the case of children. Exclusion Criteria: * Presence of general danger signs in children aged under 5 years or signs of severe malaria according to the definitions of WHO * Presence of severe malnutrition * Acute anaemia \<8g/dL * Regular medication, which may interfere with antimalarial pharmacokinetics * History of hypersensitivity reactions or contraindications to any of the drug(s) tested or used as alternative treatment(s) * A positive pregnancy test or lactating

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 181, 'type': 'ACTUAL'}}

2024-03-13