Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02389374
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Menzies School of Health Research

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.

Condition or disease Intervention/treatment Phase
Malaria Drug: chloroquine Drug: Artemether-lumefantrine combination Drug: Primaquine Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Arm Intervention/treatment
chloroquine primaquine 14days
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
Drug: chloroquine
standard dose

Drug: Primaquine
14 days

artemether-lumefantrine primaquine 1day
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Drug: Artemether-lumefantrine combination
standard dose

Drug: Primaquine
single dose

artemether-lumefantrine primaquine 14days
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Drug: Artemether-lumefantrine combination
standard dose

Drug: Primaquine
14 days




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl) [ Time Frame: day 28 ]
  2. Fractional Change in Hb Between Baseline and Day 9 and 16 [ Time Frame: day 0 and 16 ]
  3. Proportion of Patients With Anaemia Less Than 8g/dl on Day 2 [ Time Frame: on day 2 ]
  4. Proportion of Patients With Any Parasitemia on Day 3 After Treatment [ Time Frame: day 3 ]
  5. Proportion of Patients With Fever on Day 2 After Treatment [ Time Frame: day 2 ]
  6. Recurrence of Parasitaemia Within 16 Days of Follow up [ Time Frame: day 16 ]
  7. Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count [ Time Frame: day 16 ]
  8. The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients [ Time Frame: day 0 ]
  9. Frequency and Type of Variants of the G6PD Gene Within the Study Population [ Time Frame: day 0 or 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT02389374     History of Changes
Other Study ID Numbers: PR-14053
First Posted: March 17, 2015    Key Record Dates
Results First Posted: August 18, 2017
Last Update Posted: August 18, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Lumefantrine
Artemether
Primaquine
Artemether, Lumefantrine Drug Combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics