Intermittent Preventive TreatmentPhase 4SP IPTpNCT01184911
Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda
A Phase 4 study testing Sulfadoxine-pyrimethamine in people with Intermittent Preventive Treatment and Placental Malaria, run by University of California, San Francisco at 1 site in Uganda.
Trial summary
The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Intermittent Preventive Treatment, Placental Malaria
- What is being tested?
- Sulfadoxine-pyrimethamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUganda
- Study dates
- Oct 2010to Sep 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16-26 weeks gestation based on LMP or ultrasound or fundal height
- Axillary temperature <37.5 degrees C
- Informed consent
- HIV status known and negative
- Blood smear positive for falciparum malaria
Who cannot join
- History of hypersensitivity reaction to SP or components of SP
- Axillary temperature ≥37.5 degrees C
- History of receipt of antimalarials or antibiotics with antimalarial activity* in the past month
- Residence > 30 km from the ANC clinic or unwillingness to return for follow-up visits
- Hemoglobin level < 5 gm/dL
- These medications include all antimalarials, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Efficacy of Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda
The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.
- Being tested
- Sulfadoxine-pyrimethamine
- Keywords
- Malaria, Pregnancy
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxine-pyrimethamineDrug
Also called Kamsidar, Fansidar
Sulfadoxine-pyrimethamine tablets, once
| Study group | Role | What they receive |
|---|---|---|
| SP | Experimental | Asymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria Receives: Drug: Sulfadoxine-pyrimethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasite clearance
Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: Research plan changed; no longer conducting clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent Preventive TreatmentStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Uganda Malaria Surveillance Project
- Investigators
- Veronica Ades, MD, MPH, Principal investigator, University of California, San FranciscoScott Filler, MD, DTM&H, Principal investigator, Centers for Disease Control and PreventionMoses Kamya, MBChB, MMed, MPH, PhD, Principal investigator, Uganda Malaria Surveillance Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184911
- Sponsor's protocol ID
- CDC5972
- Acronym
- SP IPTp
- Status last verified
- Mar 2015
- First submitted
- 17 Aug 2010
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda
- ClinicalTrials.gov ID
- NCT01184911
- Acronym / sponsor ID
- SP IPTp / CDC5972
- Keywords
- Malaria, Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research plan changed; no longer conducting clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Uganda Malaria Surveillance Project
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 19 Aug 2010 (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.
The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SP | Experimental | Drug: Sulfadoxine-pyrimethamineAsymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 16-26 weeks gestation based on LMP or ultrasound or fundal height
- Axillary temperature <37.5 degrees C
- Informed consent
- HIV status known and negative
- Blood smear positive for falciparum malaria
Key exclusion criteria (6 listed)
- History of hypersensitivity reaction to SP or components of SP
- Axillary temperature ≥37.5 degrees C
- History of receipt of antimalarials or antibiotics with antimalarial activity* in the past month
- Residence > 30 km from the ANC clinic or unwillingness to return for follow-up visits
- Hemoglobin level < 5 gm/dL
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-pyrimethamineAlso: Kamsidar, FansidarSulfadoxine-pyrimethamine tablets, once | Drug | SP |
Primary outcome
Parasite clearance
Time frame: 42 days
Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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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.
Veronica Ades, MD, MPH principal investigator
University of California, San Francisco
Scott Filler, MD, DTM&H principal investigator
Centers for Disease Control and Prevention
Moses Kamya, MBChB, MMed, MPH, PhD principal investigator
Uganda Malaria Surveillance Project
1 site 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 in people with Intermittent Preventive Treatment and Placental Malaria, run by University of California, San Francisco at 1 site in Uganda.
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 5 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: withdrawn, as of the sponsor's last update on 5 Mar 2015. 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 Uganda. 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 withdrawn before enrolling participants, so there are no results.
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?
Parasite clearance (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2015.