ACT With Chloroquine, Amodiaquine & Sulphadoxine-Pyrimethamine in Pakistan - Full Text View

Sponsors and Collaborators:	Gates Malaria Partnership World Health Organization HealthNet International United Nations High Commissioner for Refugees Pakistan Directorate of Malaria Control
Information provided by:	Gates Malaria Partnership
ClinicalTrials.gov Identifier:	NCT00158548

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 III

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine Sulfadoxine Artesunate Fansidar Primaquine Primaquine phosphate Amodiaquine Amodiaquine hydrochloride Chloroquine Chloroquine diphosphate Chloroquine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Studies on Adding Artesunate to Existing Antimalarial Therapies With Chloroquine, Amodiaquine & Sulphadoxine-Pyrimethamine in Pakistan

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

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 International

United Nations High Commissioner for Refugees

Pakistan Directorate of Malaria Control

Investigators

Principal Investigator:

Kate Graham, MSc

HealthNet International, Peshawar, Pakistan

More Information

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

Keywords provided by Gates Malaria Partnership:

Falciparum
Vivax
Treatment
Asia

Study placed in the following topic categories:

Pyrimethamine
Artesunate
Protozoan Infections
Sulfadoxine-pyrimethamine
Amodiaquine
Primaquine
Malaria, Vivax

Chloroquine
Malaria
Sulfadoxine
Malaria, Falciparum
Folic Acid
Chloroquine diphosphate
Parasitic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Renal Agents
Antimalarials
Antiparasitic Agents
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Amebicides

Antinematodal Agents
Coccidiosis
Filaricides
Anthelmintics
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Folic Acid Antagonists
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009