A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menzies School of Health Research
• Collaborator: International Centre for Diarrhoeal Disease Research, Bangladesh
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Chloroquine; Chloroquine diphosphate; Lumefantrine; Primaquine

Criteria

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