MalariaPhase 4NCT00164255
Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy
A Phase 4 study testing sulfadoxine/pyrimethamine and sulfadoxine/pyrimethamine plus artesunate in people with Malaria, run by Centers for Disease Control and Prevention at 2 sites in Tanzania.
Trial summary
This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- sulfadoxine/pyrimethamine and sulfadoxine/pyrimethamine plus artesunate
- How many people
- 1,614 participants
- Where
- 2 sitesTanzania
- Study dates
- Jan 2003to Jun 2009
- 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 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women 15 years of age or older
- First or second pregnancy between 16 and 36 weeks gestation
Who cannot join
- Pregnancy prior to 16 weeks or after 36 weeks gestation
- Third or later pregnancy;
- Report previous allergic reactions to SP, AS, or unknown antimalarials;
- If the distance to their home is too great or too inaccessible for follow-up;
- Child's father refuses the woman's participation
Trial locations and contacts
2 sites in 1 country.
Tanzania2 sites
Kibaoni Health Centre
Ifakara, Kilombero District
St Francis Designated District Hospital
Ifakara, Kilombero District
About this study
Official title: Efficacy of Intermittent Sulfadoxine-Pyrimethamine and Sulfadoxine-Pyrimethamine + Artesunate Treatment in the Prevention of Malaria in Pregnancy in an Area With Chloroquine-Resistant Plasmodium Falciparum
This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.
- Conditions
- Malaria
- Being tested
- sulfadoxine/pyrimethamine, sulfadoxine/pyrimethamine plus artesunate
- Keywords
- malaria, birthweight, placental malaria, intermittent protective treatment, sulfadoxine/ pyrimethamine, artesuate, combination therapy, Pregnancy
- Medical subject headings
- Malaria, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulfadoxine/pyrimethamineDrug
sulfadoxine/pyrimethamine plus artesunateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
placental parasitemia
reported or noted adverse reactions
Secondary outcomes (6)
parasitemia at delivery (maternal peripheral, placental and cord)
maternal illness
birth weight
gestational age
fetal and infant health
impact of maternal HIV infection on efficacy of malaria prevention during pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Ifakara Health Research and Development Centre
- Responsible party
- Sponsor
- Investigators
- John MacArthur, MD, MPH, Principal investigator, Centers for Disease Control and PreventionSalim Abdulla, MD, PhD, Principal investigator, Ifakara Health Research and Development Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164255
- Sponsor's protocol ID
- CDC-NCID-3807
- Other IDs
- UR3/CCU018969-01
- Status last verified
- Sep 2012
- First submitted
- 9 Sep 2005
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.
PubMed 39324693
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intermittent Sulfadoxine-Pyrimethamine and Sulfadoxine-Pyrimethamine + Artesunate Treatment in the Prevention of Malaria in Pregnancy in an Area With Chloroquine-Resistant Plasmodium Falciparum
- ClinicalTrials.gov ID
- NCT00164255
- Acronym / sponsor ID
- CDC-NCID-3807
- Conditions
- Malaria
- Keywords
- malaria, birthweight, placental malaria, intermittent protective treatment, sulfadoxine/ pyrimethamine, artesuate, combination therapy, Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,614 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Ifakara Health Research and Development Centre
- Study start
- Jan 2003
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women 15 years of age or older
- First or second pregnancy between 16 and 36 weeks gestation
Key exclusion criteria (5 listed)
- Pregnancy prior to 16 weeks or after 36 weeks gestation
- Third or later pregnancy;
- Report previous allergic reactions to SP, AS, or unknown antimalarials;
- If the distance to their home is too great or too inaccessible for follow-up;
- Child's father refuses the woman's participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sulfadoxine/pyrimethamine | Drug | – |
| sulfadoxine/pyrimethamine plus artesunate | Drug | – |
Primary outcome
placental parasitemia
reported or noted adverse reactions
6 secondary outcomes
parasitemia at delivery (maternal peripheral, placental and cord)
maternal illness
birth weight
gestational age
fetal and infant health
impact of maternal HIV infection on efficacy of malaria prevention during pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
- Derived from this study: PubMed 39324693Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John MacArthur, MD, MPH principal investigator
Centers for Disease Control and Prevention
Salim Abdulla, MD, PhD principal investigator
Ifakara Health Research and Development Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sulfadoxine/pyrimethamine and sulfadoxine/pyrimethamine plus artesunate in people with Malaria, run by Centers for Disease Control and Prevention at 2 sites in Tanzania.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 parasitemia. The study lists 2 primary outcomes in all. 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 NCT00164255, 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 11 Sep 2012.