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

This study has been completed.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Ministry of Health, Ghana
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00131703
First received: August 18, 2005
Last updated: December 1, 2006
Last verified: August 2005
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


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  • Proportions of pregnant women withdrawn from the study due to the occurrence of adverse drug events (clinical and laboratory) by day 7 following initiation of treatment.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
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: 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:
ClinicalTrials.gov Identifier: NCT00131703     History of Changes
Other Study ID Numbers: ITCR5092
Study First Received: August 18, 2005
Last Updated: December 1, 2006
Health Authority: Ghana: Ministry of Health

Keywords provided by Gates Malaria Partnership:
Screening
Treatment
Amodiaquine
Sulphadoxine-pyrimethamine
Malaria in pregnancy

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Chloroquine
Chloroquine diphosphate
Pyrimethamine
Sulfadoxine
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
Anthelmintics
Central Nervous System Agents
Folic Acid Antagonists
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014