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Chlorproguanil/Dapsone Compared With Chloroquine and SP for Vivax Malaria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00158561
First Posted: September 12, 2005
Last Update Posted: January 12, 2017
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.
Collaborator:
HealthNet TPO
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
  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
Intervention Model: Parallel Assignment
Masking: None (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 Brian Greenwood, London School of Hygiene and Tropical Medicine:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158561


Locations
Pakistan
HealthNet International
Peshawar, Pakistan
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
HealthNet TPO
Investigators
Principal Investigator: Christopher Whitty, FRCP LSHTM
Study Director: Mark Rowland, PhD LSHTM
  More Information

Publications:
Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00158561     History of Changes
Other Study ID Numbers: ITDCKD45
First Submitted: September 9, 2005
First Posted: September 12, 2005
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
vivax
treatment
Asia

Additional relevant MeSH terms:
Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Pyrimethamine
Sulfadoxine
Dapsone
Fanasil, pyrimethamine drug combination
Chlorproguanil
Proguanil
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
Folic Acid Antagonists
Enzyme Inhibitors