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A Trial of Antimalarial Drugs Used in Pregnancy in Tanzania

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00146731
First Posted: September 7, 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:
National Institute for Medical Research, Tanzania
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
  Purpose
Pregnant women are vulnerable to malaria, with significant implications both for their health and for the pregnancy. Sulfadoxine-pyrimethamine (SP) is currently the first line drug for the treatment of malaria in pregnancy in Tanzania and surrounding countries, but resistance is emerging rapidly. Alternative drugs must be found, and new drugs and drug combinations are being recommended by many for deployment as first line treatment at the point that SP resistance forces a policy change. However, there are few data on the safety and efficacy of these combinations in pregnant women. This randomised trial aims to assess efficacy and safety, including birth outcome, in pregnant women with malaria in the second or third trimesters. A total of 900 pregnant women will be randomised either to standard treatment (SP) or to one of three potential drugs, or drug combinations recently recommended by a WHO expert panel. These will be SP-amodiaquine, chlorproguanil-dapsone (Lapdap), and amodiaquine-artesunate. Primary outcome will be treatment failure. Secondary outcomes will include 28 day slide clearance, maternal side effects, foetal viability and birth outcome.

Condition Intervention Phase
Malaria Drug: SP Drug: SP + amodiaquine Drug: AQ + artesunate Drug: chlorproguanil-dapsone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Malaria During Pregnancy: A Randomized Trial of Potential Options for Treatment in an Area of High Drug Resistance in Tanzania

Resource links provided by NLM:


Further study details as provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • The primary end-point of the trial will be treatment failure. This is defined above.

Secondary Outcome Measures:
  • Incidence of foetal death during treatment, defined as absence of foetal heartbeat assessed by Doppler
  • Hypoglycaemia requiring treatment
  • Parasite recrudescence or re-infection on day 28
  • Parasite clearance on day 3
  • Level of recovery of haemoglobin on day 14
  • Fever clearance time
  • Incidence of perinatal and neonatal mortality, assessed 4-6 weeks after due date of delivery
  • Clinically apparent neonatal abnormality, assessed 4-6 weeks after due date of delivery
  • Placental malaria
  • Preterm delivery
  • Other adverse events during treatment

Enrollment: 310
Study Start Date: January 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 38 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A pregnant woman who has either a positive blood smear for P.falciparum with at least 1000 asexual parasites/uL in an asymptomatic woman

or any of the following symptoms within 2 days prior to consultation:

  • history of fever;
  • headache,
  • vomiting,
  • chills/rigors,
  • and/or any of the following signs: temperature >37.50C and <39.50C, Hb>5 and <9 g/dl together with P.falciparum parasitaemia at any density

and (in both cases) the following:

  1. Has no exclusion criterion (see below);
  2. Is 14-34 weeks pregnant on the day of attending the ANC clinic or OPD;
  3. Has a viable foetus, defined by presence of foetal heartbeat by sonicaid or pinnard (foetal heartbeat is not heard until 14 weeks);
  4. Is able to take study drugs by the oral route;
  5. Is able to attend stipulated days for follow up clinic and provide specimens;
  6. Gives informed written or witnessed verbal consent to participate by herself, and also through her parent/guardian if aged <15 years (in conformity to Tanzania Law).

Exclusion Criteria:

  1. Severe and complicated forms of malaria (as defined by WHO, 1996);
  2. Pregnancy in the first trimester;
  3. A mixed plasmodial infection;
  4. Complicated pregnancy, e.g. signs/symptoms of toxaemia of pregnancy;
  5. 23 or more abortions or stillbirths;
  6. Presence of concomitant disease masking assessment of the response to treatment ;
  7. An intake of drugs contraindicated in pregnancy, e.g. tetracycline, cotrimoxazole or a macrolide antibiotic;
  8. An intake of drugs with effective antimalarial activity within the last 2 weeks.
  9. Significantly abnormal baseline haematology (except anaemia) or clinical chemistry parameters, e.g. laboratory evidence of renal impairment (serum creatinine >2 mg/dl) or of hepatitis (alanine aminotransferase [ALT] >5 times upper limit of normal);
  10. Previous participation in the study: Women having a second episode of malaria after completing the 28-day follow up will have details recorded and offered quinine but not be re-enrolled.
  11. Multiple gestation pregnancies, eg twins
  12. Mother aged 38 years or above
  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): NCT00146731


Locations
Tanzania
Muheza Designated District Hospital
Muheza, Tanga, Tanzania, PB
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
National Institute for Medical Research, Tanzania
Investigators
Study Director: Theonest K Mutabingwa, MD PhD LSHTM/NIMR
Principal Investigator: Christopher JM Whitty, FRCP LSHTM
Principal Investigator: Daniel Chandramohan, MD LSHTM
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00146731     History of Changes
Other Study ID Numbers: ITCRVG04
First Submitted: September 5, 2005
First Posted: September 7, 2005
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
malaria
pregnancy
treatment
Africa
Tanzania

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Amodiaquine
Dapsone
Chlorproguanil
Proguanil
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents
Antimetabolites