Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

12. september 2010 opdateret af: Institute of Tropical Medicine, Belgium

Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1717

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Rwanda
      • Kigali, Rwanda
        • Programme Nationale de Controle de Paludisms

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: placebo
Medicin: placebo
The control group receives placebo similar in taste and appearance to to the experimental arm
Eksperimentel: sulfadoxine-pyrimethamine
Medicin: Sulfadoxine-Pyrimethamine
The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.
Andre navne:
  • fansider

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery
maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery

Sekundære resultatmål

Resultatmål
Tidsramme
LBW = birth weight <2,500 grams
Tidsramme: at delivery
at delivery
Premature delivery = delivery prior to 37 weeks gestation
Tidsramme: at delivery
at delivery
Spontaneous miscarriage = any spontaneous abortion before the end of gestation
Tidsramme: at delivery
at delivery
Stillbirth
Tidsramme: at delivery
at delivery
Cord blood parasitaemia = presence of asexual stage parasites in thick smears
Tidsramme: at delivery
at delivery
Neonatal death = infant death within the first 28 days of life
Tidsramme: 7days and 6 weeks after delivery
7days and 6 weeks after delivery
Maternal anemia = Hb <11.0 g/dL
Tidsramme: at monthly visits between 16 weeks of gestation and delivery
at monthly visits between 16 weeks of gestation and delivery
Maternal severe anemia = Hb <6 g/dL
Tidsramme: at monthly visits between 16 weeks of gestation and delivery
at monthly visits between 16 weeks of gestation and delivery
Symptomatic maternal malaria infection = axillary temperature 37.5°C and asexual parasitaemia
Tidsramme: at monthly visits between 16 weeks of gestation and delivery
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)
Tidsramme: at monthly visits between 16 weeks of gestation and delivery plus at day 7 and week 6 after delivery
at monthly visits between 16 weeks of gestation and delivery plus at day 7 and week 6 after delivery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institute of Tropical Medicine, Belgium

Efterforskere

  • Studieleder: Umberto D'Alessandro, MD,MSc, PHD, Institute of Tropical Medicine Antwerp

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2005

Primær færdiggørelse (Faktiske)

1. april 2008

Studieafslutning (Faktiske)

1. april 2008

Datoer for studieregistrering

Først indsendt

5. september 2006

Først indsendt, der opfyldte QC-kriterier

5. september 2006

Først opslået (Skøn)

7. september 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. september 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. september 2010

Sidst verificeret

1. september 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 05 34 5 520

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Non HIV Infected Pregnant Women

Kliniske forsøg med placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Panama

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner