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

Phase 4

Completed

• Conditions: Malaria
• Interventions: Drug: Artemether-lumefantrine combination; Drug: chloroquine; Drug: Primaquine

• Registration Number: NCT02389374
• Lead Sponsor: Menzies School of Health Research

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-02-05
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-17
• Results First Submitted: 2017-01-31
• Results First Submitted QC: 2017-07-18
• Results First Posted: 2017-08-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
artemether-lumefantrine primaquine 1day	Primaquine	P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
artemether-lumefantrine primaquine 1day	Artemether-lumefantrine combination	P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
artemether-lumefantrine primaquine 14days	Artemether-lumefantrine combination	mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
artemether-lumefantrine primaquine 14days	Primaquine	mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
chloroquine primaquine 14days	chloroquine	P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine primaquine 14days	Primaquine	P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines

Primary Outcome Measures

Name	Time	Method
The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment	during follow up (day 28)	The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients With Anaemia Less Than 8g/dl on Day 2	on day 2
Proportion of Patients With Any Parasitemia on Day 3 After Treatment	day 3
Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count	day 16
The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients	day 0
Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)	day 28
Fractional Change in Hb Between Baseline and Day 9 and 16	day 0 and 16
Proportion of Patients With Fever on Day 2 After Treatment	day 2
Recurrence of Parasitaemia Within 16 Days of Follow up	day 16
Frequency and Type of Variants of the G6PD Gene Within the Study Population	day 0 or 1	Frequency and type of variants of the G6PD gene within the study population