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

Malaria Clinical Trial

Official title:

A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of Glucose-6-dehydrogenase Status in South-east Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389374
• Other study ID #: PR-14053
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2024
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• chloroquine
standard dose
• Artemether-lumefantrine combination
standard dose
• Primaquine
single dose
• Primaquine
14 days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Menzies School of Health Research	International Centre for Diarrhoeal Disease Research, Bangladesh

Outcome

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