MalariaPhase 4NCT00168948
Intermittent Antimalaria Treatment With SP in African Children
A Phase 4 study testing Sulfadoxin (12.5) Pyrimethamine (250 mg) in people with Malaria and Anemia, run by Charite University, Berlin, Germany.
Trial summary
intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana Read more about this study
- Who is it for?
- Ages 2 to 4 monthsHealthy volunteers can take part
- What is being tested?
- Sulfadoxin (12.5) Pyrimethamine (250 mg)
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Aug 2005
- 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 2 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- informed consent by parents or guardian
- no concomitant serious disease
- age >2 months
Who cannot join
- serious allergy or hypersensitivity to sulfonamides or pyrimethamine
- no severe hepatic or renal dysfunction
- serious breach of study protocol
About this study
Official title: Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial
- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana
Read the detailed description
- Sulfadoxine and pyrimethamine have long been used for malaria prevention and treatment. In this study, following suggestions of WHO, these drugs are used for intermittent treatment.
- It will be tested if this approach reduces the number of malaria attacks and ameliorates the severity of the disease
- It will also be determined if anemia due to malaria, which is prevalent in northern Ghana, may be reduced
- Moreover, the interaction between red cell polymorphisms such as HbS, HbC, alpha-thalassemia and glucose-6-phosphate dehydrogenase deficiency and SP will be examined
- Being tested
- Sulfadoxin (12.5) Pyrimethamine (250 mg)
- Keywords
- Intermittent preventive treatment, IPTi, Malaria control, Ghana
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfadoxin (12.5) Pyrimethamine (250 mg)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of IPTi with SP
Impact of IPTi on incidence on malaria attacks
Impact of IPTi on anemia
Secondary outcomes (3)
Interaction between erythrocyte polymorphisms and SP
Influence on parasite multiplicity
Impact on child development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Deutscher Akademischer Austausch Dienst
- Investigators
- Frank Mockenhaupt, PhD, Study director, Charite University-Medicine, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168948
- Sponsor's protocol ID
- 01KA0202-T
- Other IDs
- 01KA0202
- Status last verified
- Feb 2003
- First submitted
- 13 Sep 2005
- Last updated
- 2 Nov 2005
- Results posted
- No
Publications
Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7. doi: 10.1016/S0140-6736(00)04643-2.
PubMed 11377597Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50. doi: 10.1016/S0140-6736(97)04229-3.
PubMed 9310602Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Ronn AM, Theander TG, Bygbjerg IC. Effect of intermittent treatment with amodiaquine on anaemia and malarial fevers in infants in Tanzania: a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1853-60. doi: 10.1016/s0140-6736(03)13504-0.
PubMed 12788572
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00168948
- Acronym / sponsor ID
- 01KA0202-T
- Keywords
- Intermittent preventive treatment, IPTi, Malaria control, Ghana
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Deutscher Akademischer Austausch Dienst
- Study start
- Mar 2003
- Study completion
- Aug 2005
- First posted
- 15 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.
- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana
Detailed description
- Sulfadoxine and pyrimethamine have long been used for malaria prevention and treatment. In this study, following suggestions of WHO, these drugs are used for intermittent treatment.
- It will be tested if this approach reduces the number of malaria attacks and ameliorates the severity of the disease
- It will also be determined if anemia due to malaria, which is prevalent in northern Ghana, may be reduced
- Moreover, the interaction between red cell polymorphisms such as HbS, HbC, alpha-thalassemia and glucose-6-phosphate dehydrogenase deficiency and SP will be examined
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 2 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- informed consent by parents or guardian
- no concomitant serious disease
- age >2 months
Key exclusion criteria (3 listed)
- serious allergy or hypersensitivity to sulfonamides or pyrimethamine
- no severe hepatic or renal dysfunction
- serious breach of study protocol
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 |
|---|---|---|
| Sulfadoxin (12.5) Pyrimethamine (250 mg) | Drug | – |
Primary outcome
Efficacy and safety of IPTi with SP
Impact of IPTi on incidence on malaria attacks
Impact of IPTi on anemia
3 secondary outcomes
Interaction between erythrocyte polymorphisms and SP
Influence on parasite multiplicity
Impact on child development
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2005.
- Background: PubMed 11377597Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7. doi: 10.1016/S0140-6736(00)04643-2.
- Background: PubMed 9310602Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50. doi: 10.1016/S0140-6736(97)04229-3.
- Background: PubMed 12788572Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Ronn AM, Theander TG, Bygbjerg IC. Effect of intermittent treatment with amodiaquine on anaemia and malarial fevers in infants in Tanzania: a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1853-60. doi: 10.1016/s0140-6736(03)13504-0.
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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.
Frank Mockenhaupt, PhD study director
Charite University-Medicine, Berlin, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfadoxin (12.5) Pyrimethamine (250 mg) in people with Malaria and Anemia, run by Charite University, Berlin, Germany.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Efficacy and safety of IPTi with SP. The study lists 3 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 NCT00168948, which also lists 3 linked publications.
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 2 Nov 2005.