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

NCT02389374 | Completed Phase 4 Results

• 1 other identifier: PR-14053
• Study Type: interventional
• Target: 181
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment

  The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28

  during follow up (day 28)

Secondary Outcomes (9)

• 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 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 With Fever on Day 2 After Treatment

  day 2

Study Arms (3)

chloroquine primaquine 14days

OTHER

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

Drug: chloroquine; Drug: Primaquine

artemether-lumefantrine primaquine 1day

OTHER

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

Drug: Artemether-lumefantrine combination; Drug: Primaquine

artemether-lumefantrine primaquine 14days

OTHER

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

Drug: Artemether-lumefantrine combination; Drug: Primaquine

Interventions

chloroquine DRUG

standard dose

chloroquine primaquine 14days

Artemether-lumefantrine combination DRUG

standard dose

artemether-lumefantrine primaquine 14days; artemether-lumefantrine primaquine 1day

Primaquine DRUG

single dose

artemether-lumefantrine primaquine 1day

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Menzies School of Health Research: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Related Publications (2)

• 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.

  PMID: 28806961 DERIVED

• 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.

  PMID: 27128675 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Chloroquine; Artemether, Lumefantrine Drug Combination; Primaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Benedikt Ley
• Organization: Menzies School of Health Research

benedikt.ley@menzies.edu.au

889468643

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: March 17, 2015
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 13, 2024
• Results First Posted: August 18, 2017

Record last verified: 2024-03