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IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda

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ClinicalTrials.gov Identifier: NCT00372632
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
Institute of Tropical Medicine, Belgium

Tracking Information
First Submitted Date  ICMJE September 5, 2006
First Posted Date  ICMJE September 7, 2006
Last Update Posted Date September 14, 2010
Study Start Date  ICMJE December 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2010)
malaria infection will be defined as the presence of asexual stage parasites on thick smears made with maternal side placental blood and Maternal peripheral blood [ Time Frame: maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
  • Placental malaria infection will be defined as the presence of asexual stage parasites on thick smears made with maternal side placental blood;
  • Maternal peripheral parasitaemia will be defined as the presence of asexual stage parasites in thick smears made from maternal peripheral venous blood.
Change History Complete list of historical versions of study NCT00372632 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2010)
  • LBW = birth weight <2,500 grams [ Time Frame: at delivery ]
  • Premature delivery = delivery prior to 37 weeks gestation [ Time Frame: at delivery ]
  • Spontaneous miscarriage = any spontaneous abortion before the end of gestation [ Time Frame: at delivery ]
  • Stillbirth [ Time Frame: at delivery ]
  • Cord blood parasitaemia = presence of asexual stage parasites in thick smears [ Time Frame: at delivery ]
  • Neonatal death = infant death within the first 28 days of life [ Time Frame: 7days and 6 weeks after delivery ]
  • Maternal anemia = Hb <11.0 g/dL [ Time Frame: at monthly visits between 16 weeks of gestation and delivery ]
  • Maternal severe anemia = Hb <6 g/dL [ Time Frame: at monthly visits between 16 weeks of gestation and delivery ]
  • Symptomatic maternal malaria infection = axillary temperature 37.5°C and asexual parasitaemia [ Time Frame: at monthly visits between 16 weeks of gestation and delivery ]
  • Severe maternal adverse reactions to SP = severe cutaneous reactions (e.g., erythema multiform, Stevens-Johnson syndrome, or toxic epidermal necrolysis) [ Time Frame: at monthly visits between 16 weeks of gestation and delivery plus at day 7 and week 6 after delivery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
  • LBW = birth weight <2,500 grams
  • Premature delivery = delivery prior to 37 weeks gestation
  • Spontaneous miscarriage = any spontaneous abortion before the end of gestation
  • Stillbirth
  • Cord blood parasitaemia = presence of asexual stage parasites in thick smears
  • Neonatal death = infant death within the first 28 days of life
  • Maternal anemia = Hb <11.0 g/dL
  • Maternal severe anemia = Hb <6 g/dL
  • Symptomatic maternal malaria infection = axillary temperature 37.5oC and asexual parasitaemia
  • Severe maternal adverse reactions to SP = severe cutaneous reactions (e.g., erythema multiform, Stevens-Johnson syndrome, or toxic epidermal necrolysis)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda
Official Title  ICMJE Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda
Brief Summary The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment
Detailed Description

The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment.

This will be a randomized blinded placebo controlled trial: women in the 16-28th week of gestation will be offered enrolment into the study and randomized to receive IPT/SP regimen or placebo once during the second and once in the third trimesters.

The study will be conducted in Mashesha (estimated SP drug resistance 20%, 12% in 2000), Kicukiro (40% SP resistance) and Rukara (60% SP resistance). In each of these sites there are about 1000 deliveries per year. According to DHMT data, over 75% of pregnant women attend antenatal clinics, usually booking between 15 and 25 weeks of gestation. Based on this study we expect to find placental malaria prevalence over 50% in all sites.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non HIV Infected Pregnant Women
Intervention  ICMJE
  • Drug: Sulfadoxine-Pyrimethamine
    The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.
    Other Name: fansidar
  • Drug: placebo
    The control group receives placebo similar in taste and appearance to to the experimental arm
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: sulfadoxine-pyrimethamine
    Intervention: Drug: Sulfadoxine-Pyrimethamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2010)
1717
Original Enrollment  ICMJE
 (submitted: September 5, 2006)
2250
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pregnant women between 16-28 weeks of gestation;
  2. Residence within the catchment's area of the health facility;
  3. Willing to deliver at the health facility;
  4. Willing to ; adhere to all requirements of the study;
  5. Willing to provide written informed consent;
  6. Aged 21 years and above

Exclusion Criteria:

  1. Severe anemia (Hb < 6 g/dL)
  2. History of allergic reactions to sulfa drugs;
  3. Taking other sulfa drugs as CTX;
  4. History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);
  5. History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization;
  6. Any significant illness that requires hospitalization;
  7. Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;
  8. Prior enrollment in the study or concurrent enrollment in another study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Rwanda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00372632
Other Study ID Numbers  ICMJE 05 34 5 520
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Programme Nationale Lutte integré contre le Paludism, Ministère de la Santé
Study Sponsor  ICMJE Institute of Tropical Medicine, Belgium
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Umberto D'Alessandro, MD,MSc, PHD Institute of Tropical Medicine, Antwerp
PRS Account Institute of Tropical Medicine, Belgium
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP