Efficacy and Safety of Sulphadoxine-Pyrimethamine and Amodiaquine in Ghanaian Pregnant Women - Full Text View

Sponsor:	Gates Malaria Partnership
Collaborators:	London School of Hygiene and Tropical Medicine Ministry of Health, Ghana
Information provided by:	Gates Malaria Partnership
ClinicalTrials.gov Identifier:	NCT00131703

Purpose

Malaria in pregnancy is potentially fatal to both the mother and the foetus particularly in the primigravidae. Implementation of appropriate control and preventive measures is challenged by the fact that malaria infection in pregnancy is often asymptomatic and parasitized red blood cells sequestrated in the placental microcirculation may not be detectable in the peripheral blood. In addition, the widespread prevalence of parasites resistant to chloroquine and sulphadoxine-pyrimethamine (SP) and, the safety concerns about newer antimalarials, poverty and inadequate supply have made antimalarial treatment options available to pregnant women very limited. These have necessitated an urgent search for alternative safe and efficacious treatment options for pregnant women. The objective of this study is to assess the efficacy, safety and tolerability of four antimalarial treatment options in rural Ghana within a programme setting.

Condition	Intervention	Phase
Malaria Pregnancy	Drug: Amodiaquine Drug: Sulphadoxine-pyrimethamine Drug: Chloroquine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised Double Blind Clinical Trial of Amodiaquine (AQ) and Sulphadoxine-Pyrimethamine (SP) Used Singly and in Combination (AQ+SP) Compared With Chloroquine (CQ) in the Treatment of Falciparum Malaria Infection in Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Malaria

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

U.S. FDA Resources

Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:

Prevalence of parasitaemia on day 28 post treatment.
Prevalence of parasitaemia on day 14 post treatment.

Secondary Outcome Measures:

Incidence of adverse drug events within seven days following treatment.
Proportions of pregnant women withdrawn from the study due to the occurrence of adverse drug events (clinical and laboratory) by day 7 following initiation of treatment.
Change in maternal haemoglobin concentrations at days 14 and 28 following treatment.
Prevalence of peripheral parasitaemia at delivery.
Prevalence of placental parasitaemia at delivery.
Proportions of abnormal biochemistry and white blood cell values on days 14 and 28 post treatment.
Sensitivity, specificity, positive and negative predictive values, likelihood ratios, and the area under receiver operating characteristic (ROC) curve for the OptiMAL antigen test.
Incidences of adverse pregnancy outcomes in the study group.
Prevalence of postpartum parasitaemia.
Prevalence of postpartum anaemia.

Estimated Enrollment:	900
Study Start Date:	March 2003
Estimated Study Completion Date:	March 2005

Show Detailed Description

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Gestational age of at least 16 weeks.
P. falciparum parasitaemia of any density with or without symptoms.
Informed consent.
No known adverse reaction to any of the study drugs.
Residence in the study area.

Exclusion Criteria:

Past obstetric and medical history that might adversely affect the interpretation of outcomes such as repeated stillbirths and eclampsia.
History of severe adverse drug reactions to co-trimoxazole in the past.
Haemoglobin concentration below 5.0 g/dl.
Severe malaria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131703

Sponsors and Collaborators

Gates Malaria Partnership

London School of Hygiene and Tropical Medicine

Ministry of Health, Ghana

Investigators

Principal Investigator:

Harry K Tagbor, MD

London School of Hygiene and Tropical Medicine

More Information

Publications:

Tagbor H, Bruce J, Browne E, Randal A, Greenwood B, Chandramohan D. Efficacy, safety, and tolerability of amodiaquine plus sulphadoxine-pyrimethamine used alone or in combination for malaria treatment in pregnancy: a randomised trial. Lancet. 2006 Oct 14;368(9544):1349-56.

Study ID Numbers:	ITCR5092
Study First Received:	August 18, 2005
Last Updated:	December 1, 2006
ClinicalTrials.gov Identifier:	NCT00131703 History of Changes
Health Authority:	Ghana: Ministry of Health

Keywords provided by Gates Malaria Partnership:

Screening
Treatment
Amodiaquine
Sulphadoxine-pyrimethamine
Malaria in pregnancy

Additional relevant MeSH terms:

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

Analgesics
Antinematodal Agents
Protozoan Infections
Sulfadoxine-pyrimethamine
Amodiaquine
Filaricides
Coccidiosis
Chloroquine
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Anthelmintics
Folic Acid Antagonists
Sulfadoxine
Pharmacologic Actions
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on February 08, 2010