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MalariaPhase 4IPTpRCTNCT00964691

A Randomized Controlled Trial for Intermittent Preventive Treatment in Pregnancy With Fansidar in Solomon Islands

A Phase 4 study testing Sulphadoxine-pyrimethamine and Chloroquine prophylaxis in people with Malaria and Malaria in Pregnancy, run by Ministry of Health and Medical Services, Solomon Islands at 1 site in Solomon Islands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the effectiveness of intermittent preventive treatment in pregnancy (IPTp) with Sulphadoxine-pyrimethamine compared to chloroquine prophylaxis in Honiara, Solomon Islands for prevention of malaria and it's adverse effects in pregnancy. Read more about this study

Who is it for?
Ages 15 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Malaria, Malaria in Pregnancy
What is being tested?
Sulphadoxine-pyrimethamine and Chloroquine prophylaxis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,504 participants
Where
1 siteSolomon Islands
Study dates
Aug 2009to Aug 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Pregnant women aged 15 to 49 years
  • Attending ANC clinic for the first time in this pregnancy
  • Assigned routine ANC at a HCC health clinic
  • Has experienced quickening (feeling the movements of the fetus)
  • Gestation of 16 weeks to 32 weeks (as assessed by the last menstrual period [LMP] or by palpation if LMP is not available)
  • Willing to adhere to all requirements of study
  • Willing to provide informed written consent
  • Planning to stay in Honiara for antenatal care and delivery

Who cannot join

  • Used chloroquine prophylaxis in the current pregnancy before this ANC visit
  • A history of allergic reaction to sulfa drugs (SP or cotrimoxazole
  • Haemoglobin of < 7 g/dl
  • Using folic acid in a dose of 5 mg daily (a dose of 1 mg daily or less is acceptable)
  • Not willing to adhere to study requirements
  • Women who are severely ill

Trial locations and contacts

1 site in 1 country.

Solomon Islands1 site

  • Honiara City Council

    Honiara

About this study

Official title: Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine Versus Weekly Chloroquine Prophylaxis During Pregnancy in Solomon Islands: a Randomized Controlled Trial

The purpose of this study is to assess the effectiveness of intermittent preventive treatment in pregnancy (IPTp) with Sulphadoxine-pyrimethamine compared to chloroquine prophylaxis in Honiara, Solomon Islands for prevention of malaria and it's adverse effects in pregnancy.

Read the detailed description

Malaria is a major health problem in the Solomon Islands, with an annual estimated incidence of 158 per 1000 population in 2005, and P. falciparum and P. vivax responsible for respectively 71% and 29% of the clinical cases. Not much is known about the burden of malaria in pregnancy and the effectiveness of weekly chloroquine prophylaxis, the national policy for the prevention of malaria in pregnancy. In Honiara, the capital, 42.7% of the pregnant women are anaemic at their first antenatal clinic (ANC) visit. In a national data-base, clinical malaria in pregnancy was associated with an increased risk of anaemia. High levels of chloroquine drug resistance have been reported (67% treatment failure at day 28 in 2001). Among women who attended an ANC in Honiara and had been offered chloroquine prophylaxis, a high low birth weight risk among primigravidae compared to multigravidae was noted. This information indicates that the current policy may not be optimal for the prevention of malaria and its effects in pregnancy. Intermittent preventive treatment (IPTp) with sulfadoxine-pyrimethamine (SP) in pregnancy is an alternative strategy which has been introduced in many malarious countries in sub-Saharan Africa. Studies which compared IPTp with chloroquine prophylaxis in Africa showed that IPTp was more beneficial. Resistance to SP monotherapy in the Solomon islands has not been examined; however, the resistance to the combination of SP and chloroquine is low (< 10%). IPTp with SP has so far not been implemented in a region where P. vivax is common, and the effect of SP on P. vivax is not clear.

We propose a randomized controlled trial to assess the effectiveness of IPTp with SP compared to chloroquine prophylaxis in Honiara, the Solomon Islands. As outcome measures we will examine the effect on anaemia in third trimester, placental malaria, maternal anaemia at the time of delivery, infant birth weight, and prematurity. Outcomes in women allocated IPTp with SP will be compared with those allocated chloroquine prophylaxis. We expect 2504 women from Honiara City Council to participate in the randomised controlled trial. To assess the burden of malaria in pregnancy in other locations women we expect 1000 women to participate in a survey at the time of delivery among women not participating in the trial. At the end of this study, we will know the burden of malaria in pregnancy in Honiara and Guadalcanal, and we will be able to assist in developing evidence based national guidelines for malaria prevention among pregnant women in the Solomon Islands. The information obtained will be important for other areas and countries with a similar epidemiology of malaria in pregnancy.

Being tested
Sulphadoxine-pyrimethamine, Chloroquine prophylaxis
Keywords
malaria, IPTp, Fansidar, Intermittent Preventive Treatment in pregnancy, pregnancy, prophylaxis, Chloroquine, Anemia, Prevention, Placental malaria, Solomon Islands, Low birth weight
Medical subject headings
Malaria, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sulphadoxine-pyrimethamineDrug

    Also called Fansidar, IPTp/SP, SP

    3 tablets of SP (500 mg sulfadoxine and 25 mg pyrimethamine per tablet) by mouth under supervision at enrolment, and 3 tablets of SP under supervision 4 to 12 weeks later in pregnancy (timing of second dose depends upon gestation at first dose)

  • Chloroquine prophylaxisDrug

    Also called CQ

    300 mg weekly by mouth from the enrolment date until delivery. Only the enrolment dose will be supervised.

Study groups in NCT00964691
Study groupRoleWhat they receive
Chloroquine prophylaxisActive comparator300 mg weekly by mouth from the enrolment date until delivery. Only the enrolment dose will be supervised.
Receives: Drug: Chloroquine prophylaxis
IPTp with Sulphadoxine-pyrimethamineActive comparator3 tablets of SP (500 mg sulfadoxine and 25 mg pyrimethamine per tablet) by mouth under supervision at enrolment, and 3 tablets of SP under supervision 4 to 12 weeks later in pregnancy (timing of second dose depends upon gestation at first dose)
Receives: Drug: Sulphadoxine-pyrimethamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Placental malaria among primigravidae at time of delivery

    Measured: 12 months

Secondary outcomes (4)

  1. Low birth weight among primigravidae

    Measured: 12 months

  2. Maternal anaemia (Hb <11 g/dl) in the third trimester

    Measured: 12 months

  3. Maternal anaemia (Hb <11 g/dl) at delivery

    Measured: 12 months

  4. Malaria parasitemia at delivery

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionAug 2010 (estimated)
  4. Study completionAug 2010 (estimated)

Why it stopped: Low prevalence of malaria, high prevalence of reported allergy to sulphur drugs, high proportion of women not meeting the inclusion criterea.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,504 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00964691
Sponsor's protocol ID
01-2009
Acronym
IPTpRCT
Status last verified
Jul 2010
First submitted
24 Aug 2009
Last updated
7 Jul 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Wini L, Appleyard B, Bobogare A, Pikacha J, Seke J, Tuni M, Hou L, Hii J, McCarthy J, van Eijk AM. Intermittent preventive treatment with sulfadoxine-pyrimethamine versus weekly chloroquine prophylaxis for malaria in pregnancy in Honiara, Solomon Islands: a randomised trial. Malariaworld J. 2013 Jun 29;4:12. doi: 10.5281/zenodo.10894954. eCollection 2013.

    PubMed 38828109

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sulphadoxine-pyrimethamine and Chloroquine prophylaxis in people with Malaria and Malaria in Pregnancy, run by Ministry of Health and Medical Services, Solomon Islands at 1 site in Solomon Islands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Solomon Islands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low prevalence of malaria, high prevalence of reported allergy to sulphur drugs, high proportion of women not meeting the inclusion criterea.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Placental malaria among primigravidae at time of delivery (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00964691, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.

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