Chlorproguanil/Dapsone Compared With Chloroquine and SP for Vivax Malaria

This study has been completed.
Sponsor:
Collaborator:
HealthNet TPO
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00158561
First received: September 9, 2005
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

To determine whether two cheap antifolates (chlorproguanil-dapsone and sulfadoxine-pyrimethamine) which work against falciparum malaria in this region are sufficiently effective against vivax malaria to be deployed in areas where diagnosis is poor and the burden of malaria is high, a randomised controlled trial of the three drugs is being undertaken comparing their efficacy in treating malaria.


Condition Intervention Phase
Malaria
Vivax Malaria
Drug: sulfadoxine-pyrimethamine and chlorproguanil-dapsone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: An Open-Label Three Arm Trial of the Efficacy and Safety of Chlorproguanil / Dapsone (Lapdap) Compared With Chloroquine and Sulfadoxine / Pyrimethamine for the Treatment of Vivax Malaria in Pakistan and Afghanistan

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Day 14 slide clearance rate (complete clearance of parasites), assessed by microscopists who are blind to treatment allocation.

Secondary Outcome Measures:
  • Day 28 slide clearance rate defined as the number of treated patients with clearance of parasitaemia within 14 days of starting treatment, without subsequent recrudescence up to day 28.
  • Day 14 clinical failure rate (presence of symptoms of malaria in the presence of parasitaemia).
  • Day 28 clinical failure rate.
  • Adverse events.
  • Haemoglobin level increased by at least 1g/dl by day 14.
  • Clearance of gametocytaemia by day 3, 7, and 14.
  • Number of subsequent malaria episodes in next 6 months. It is assumed that the population of each treatment arm is equally likely to be re-infected in this time scale. Therefore any measurable difference in number of subsequent episodes between treatment
  • In G6PD deficient patients the change in mean haemoglobin.

Estimated Enrollment: 750
Study Start Date: February 2004
Study Completion Date: March 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Presentation at BHU or clinic with probable clinical malaria.
  2. Infection with P. vivax, confirmed by microscopy.
  3. Age 3 years or older (no restriction on upper age limit).
  4. Written or witnessed verbal consent obtained from the patient or the patients parent or guardian.
  5. Married women of child bearing age confirmed to be non-pregnant at outset and willing to remain thus for the duration of the study.
  6. Willingness to comply with the requirements of the protocol and particularly to provide venous and thumb prick blood samples.
  7. Available for follow up for the duration of the study and not less than 6 months.
  8. Willingness to report to the BHU or clinic if they feel unwell in the 6 months following completion (i.e. 7 months from enrolment date). NB these patients will only be those recruited up to 7 months before the end of the study period.
  9. Availability of G6PD status by willingness to be tested at admission.

Exclusion Criteria:

  1. General condition requiring hospital admission.
  2. Evidence of any concomitant infection likely to mask treatment response at the time of presentation.
  3. Presence of any other underlying disease that compromises the diagnosis and the evaluation of the response to the study medication.
  4. History of allergy to sulphonamides, dapsone or chloroquine or hypersensitivity to biguanides (eg proguanil, chlorproguanil) sulphones (eg frusemide, thiazides, acetazolamide, and sulphonylureas) or any other tablet contents.
  5. Known methaemoglobin reductase deficiency and haemoglobin M.
  6. Treatment within the past twenty-eight days with sulfadoxine/pyrimethamine (Fansidar), sulfalene/pyrimethamine (Metakelfin), mefloquine-sulfadoxine-pyrimethamine (Fansimef); 21-days with mefloquine, or 7-days with amodiaquine, chloroquine, halofantrine, quinine (full course), primaquine, atovaquone - proguanil, artemisinin derivatives, co-artemether, trimethoprim, chloramphenicol, erythromycin, tetracycline or clindamycin.
  7. Visible jaundice.
  8. Use of an investigational drug within 30 days or 5 half-lives whichever is the longer.
  9. Severe anaemia (Hb<7 g/dl).
  10. Other species of malaria seen.
  11. Pregnancy, assessed by pregnancy test in all married women of child-bearing age (age over 14 and under 50).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158561

Locations
Pakistan
HealthNet International
Peshawar, Pakistan
Sponsors and Collaborators
Gates Malaria Partnership
HealthNet TPO
Investigators
Principal Investigator: Christopher Whitty, FRCP LSHTM
Study Director: Mark Rowland, PhD LSHTM
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00158561     History of Changes
Other Study ID Numbers: ITDCKD45
Study First Received: September 9, 2005
Last Updated: March 5, 2009
Health Authority: Pakistan: Ministry of Health
Afghanistan: Ministry of Public Health

Keywords provided by Gates Malaria Partnership:
vivax
treatment
Asia

Additional relevant MeSH terms:
Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Chloroquine
Dapsone
Pyrimethamine
Sulfadoxine
Chlorproguanil
Proguanil
Fanasil, pyrimethamine drug combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimetabolites

ClinicalTrials.gov processed this record on August 28, 2014