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

Menzies School of Health Research

Status and phase: Completed; Phase 4

Conditions: Malaria

Treatments: Drug: Primaquine; Drug: chloroquine; Drug: Artemether-lumefantrine combination

Study type: Interventional

Funder types: Other

Identifiers

NCT02389374

PR-14053

Details and patient eligibility

About

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.

Full description

The national guidelines for the treatment of uncomplicated malaria in Bangladesh currently recommend a standard dose of artemether-lumefantrine followed by a single dose of primaquine for P. falciparum malaria and a three day course of chloroquine followed by 14 days of primaquine for vivax malaria.Currently the national treatment guidelines do not include any testing for G6PD deficiency before treatment with primaquine. In order to guarantee safe and efficacious treatment for all patients diagnosed with uncomplicated malaria in Bangladesh, it is essential to monitor the effectiveness and safety of the recommended treatment guidelines. This trial therefore evaluates the local efficacy and safety of the current first line treatment and assesses the G6PD status of the enrolled patients.

Patients with uncomplicated malaria attending the health care center, who meet the study inclusion criteria will be enrolled, treated on site and followed up for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. The study will provide efficacy data for both artemether-lumefantrine and chloroquine and will generate data on G6PD status in the region, which will provide vital information for policy makers in regards to the wider roll out of primaquine for the radical cure of vivax malaria.

Enrollment: 181 patients

Sex: All

Ages: 12+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 3 patient groups

chloroquine primaquine 14days

Other group

Description:

P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines

Treatment:

Drug: Primaquine

Drug: chloroquine

Drug: Primaquine

artemether-lumefantrine primaquine 1day

Other group

Description:

P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines

Treatment:

Drug: Primaquine

Drug: Primaquine

Drug: Artemether-lumefantrine combination

artemether-lumefantrine primaquine 14days

Other group

Description:

mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines

Treatment:

Drug: Primaquine

Drug: Primaquine

Drug: Artemether-lumefantrine combination