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

NCT ID: NCT02389374

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-03-31

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.

Conditions

Malaria

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chloroquine primaquine 14days

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

Group Type: OTHER

chloroquine

Intervention Type: DRUG

standard dose

Primaquine

Intervention Type: DRUG

14 days

artemether-lumefantrine primaquine 1day

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

Group Type: OTHER

Artemether-lumefantrine combination

Intervention Type: DRUG

standard dose

Primaquine

Intervention Type: DRUG

single dose

artemether-lumefantrine primaquine 14days

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

Group Type: OTHER

Artemether-lumefantrine combination

Intervention Type: DRUG

standard dose

Primaquine

Intervention Type: DRUG

14 days

Interventions

chloroquine

standard dose

Intervention Type: DRUG

Artemether-lumefantrine combination

standard dose

Intervention Type: DRUG

Primaquine

single dose

Intervention Type: DRUG

Primaquine

14 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

Menzies School of Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Alam MS, Ley B, Nima MK, Johora FT, Hossain ME, Thriemer K, Auburn S, Marfurt J, Price RN, Khan WA. Molecular analysis demonstrates high prevalence of chloroquine resistance but no evidence of artemisinin resistance in Plasmodium falciparum in the Chittagong Hill Tracts of Bangladesh. Malar J. 2017 Aug 15;16(1):335. doi: 10.1186/s12936-017-1995-5.

Reference Type: DERIVED

PMID: 28806961 (View on PubMed)

Ley B, Alam MS, Thriemer K, Hossain MS, Kibria MG, Auburn S, Poirot E, Price RN, Khan WA. G6PD Deficiency and Antimalarial Efficacy for Uncomplicated Malaria in Bangladesh: A Prospective Observational Study. PLoS One. 2016 Apr 29;11(4):e0154015. doi: 10.1371/journal.pone.0154015. eCollection 2016.

Reference Type: DERIVED

PMID: 27128675 (View on PubMed)

Other Identifiers

PR-14053

Identifier Type: -

Identifier Source: org_study_id