ACT With Chloroquine, Amodiaquine & Sulphadoxine-Pyrimethamine in Pakistan

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
HealthNet TPO
United Nations High Commissioner for Refugees
Pakistan Directorate of Malaria Control
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00158548
First received: September 8, 2005
Last updated: July 3, 2007
Last verified: June 2007
  Purpose

Chloroquine resistant falciparum malaria in Pakistan is prevalent in every malarious area examined. Resistance to the favoured second-line treatment, sulphadoxine-pyrimethamine S/P is rising fast. To avert a repetition of the resistance catastrophe that occurred in SE Asia it is critical to preserve the effective life of SP by using it in combination with artesunate. Efficacy of ACT with artesunate in combination with chloroquine, SP or amodiaquine for treatment of malaria (falciparum or vivax) will be examined in malaria patients in Pakistan.


Condition Intervention Phase
Malaria
Falciparum Malaria
Vivax Malaria
Drug: SP, chloroquine, amodiaquine, primaquine, artesunate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Studies on Adding Artesunate to Existing Antimalarial Therapies With Chloroquine, Amodiaquine & Sulphadoxine-Pyrimethamine in Pakistan

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Day 7 slide clearance rate (complete clearance of trophozoites) assessed by microscopists who are blind to treatment allocation.
  • Day 28 slide clearance rate without subsequent recrudescence.
  • Day 7 gametocyte prevalence.

Secondary Outcome Measures:
  • Day 14 gametocyte prevalence
  • Fever clearance time
  • cure rate (elimination of parasitaemia without recrudescence).
  • Rate and time of parasite clearance.
  • Rate of resolution of fever.
  • Proportion of gametocyte carriers.
  • Transmissibility of gametocytes through mosquito feeding studies.
  • Tolerability.
  • Molecular characterisation of genetic diversity and resistance before and after treatment.

Enrollment: 650
Study Start Date: June 2001
Study Completion Date: December 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults or children > 5 yrs
  • weight > 5 kg
  • monoinfection with P. falciparum or P. vivax
  • history of recent fever
  • consent from patient or parent.

Exclusion Criteria:

  • patients with signs of severe malaria.
  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: NCT00158548

Locations
Pakistan
HealthNet International
Peshawar, Pakistan
Sponsors and Collaborators
Gates Malaria Partnership
World Health Organization
HealthNet TPO
United Nations High Commissioner for Refugees
Pakistan Directorate of Malaria Control
Investigators
Principal Investigator: Kate Graham, MSc HealthNet International, Peshawar, Pakistan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00158548     History of Changes
Other Study ID Numbers: ITDCVC98, ITDCVV98
Study First Received: September 8, 2005
Last Updated: July 3, 2007
Health Authority: Pakistan: Ministry of Health
Pakistan: Research Ethics Committee

Keywords provided by Gates Malaria Partnership:
Falciparum
Vivax
Treatment
Asia

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Amodiaquine
Chloroquine
Chloroquine diphosphate
Primaquine
Pyrimethamine
Sulfadoxine
Artesunate
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides
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

ClinicalTrials.gov processed this record on August 26, 2014