- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02389374
A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh
A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of Glucose-6-dehydrogenase Status in South-east Bangladesh
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: chloroquine primaquine 14days
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
|
standard dose
single dose
14 days
|
Other: artemether-lumefantrine primaquine 1day
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
|
single dose
14 days
standard dose
|
Other: artemether-lumefantrine primaquine 14days
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
|
single dose
14 days
standard dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment
Time Frame: during follow up (day 28)
|
The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28
|
during follow up (day 28)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)
Time Frame: day 28
|
day 28
|
|
Fractional Change in Hb Between Baseline and Day 9 and 16
Time Frame: day 0 and 16
|
day 0 and 16
|
|
Proportion of Patients With Anaemia Less Than 8g/dl on Day 2
Time Frame: on day 2
|
on day 2
|
|
Proportion of Patients With Any Parasitemia on Day 3 After Treatment
Time Frame: day 3
|
day 3
|
|
Proportion of Patients With Fever on Day 2 After Treatment
Time Frame: day 2
|
day 2
|
|
Recurrence of Parasitaemia Within 16 Days of Follow up
Time Frame: day 16
|
day 16
|
|
Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count
Time Frame: day 16
|
day 16
|
|
The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients
Time Frame: day 0
|
day 0
|
|
Frequency and Type of Variants of the G6PD Gene Within the Study Population
Time Frame: day 0 or 1
|
Frequency and type of variants of the G6PD gene within the study population
|
day 0 or 1
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Mosquito-Borne Diseases
- Malaria
- Anti-Infective Agents
- Antirheumatic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Amebicides
- Chloroquine
- Lumefantrine
- Artemether
- Primaquine
- Artemether, Lumefantrine Drug Combination
Other Study ID Numbers
- PR-14053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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