Clinical trial NCT02389374: A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh
Official title: A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of Glucose-6-dehydrogenase Status in South-east Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2015-03-17
Enrollment: 181
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment
timeFrame: during follow up (day 28)
Secondary outcomes:
measure: Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)
timeFrame: day 28
measure: Fractional Change in Hb Between Baseline and Day 9 and 16
timeFrame: day 0 and 16
measure: Proportion of Patients With Anaemia Less Than 8g/dl on Day 2
timeFrame: on day 2
measure: Proportion of Patients With Any Parasitemia on Day 3 After Treatment
timeFrame: day 3
measure: Proportion of Patients With Fever on Day 2 After Treatment
timeFrame: day 2
measure: Recurrence of Parasitaemia Within 16 Days of Follow up
timeFrame: day 16
measure: Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count
timeFrame: day 16
measure: The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients
timeFrame: day 0
measure: Frequency and Type of Variants of the G6PD Gene Within the Study Population
timeFrame: day 0 or 1
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.