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MalariaPhase 4NCT00206739

Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants

A Phase 4 study testing Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg) in people with Malaria and Anemia, run by Bernhard Nocht Institute for Tropical Medicine at 1 site in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks, episodes of anemia, and the overall morbidity and mortality Read more about this study

Who is it for?
Ages 2 to 4 monthsHealthy volunteers can take part
Conditions the study is for
Malaria, Anemia
What is being tested?
Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)
How many people
1,070 participants
Where
1 siteGhana
Study dates
Jan 2003to Sep 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 parent/guardian (written or oral)
  • Permanent residentship in the study area
  • Age of 3 months +/-4 weeks

Who cannot join

  • Hypersensitivity to sulfonamides or pyrimethamine (skin rashes, evidence of hemolysis including dark urine and/or purpura, presumptive signs of bone marrow depression such as sore throat and/or mouth ulcers)
  • Other severe adverse events related to pyrimethamine-sulfadoxine application
  • Signs of severe hepatic or renal dysfunction not due to malaria
  • Other reasons after decision of the study physician

Trial locations and contacts

1 site in 1 country.

Ghana1 site

  • Kumasi Centre for Collaborative Research in Tropical Medicine

    Kumasi, Ashanti Region

Other trials in Ghana

About this study

Official title: Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infant: a Randomized, Double-blind, and Placebo-controlled Clinical Trial

The purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks, episodes of anemia, and the overall morbidity and mortality

Read the detailed description

In order to define the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine, a novel principle of malaria intervention, the following parameters are evaluated: i) the level of protection from malaria attacks and episodes of anemia during the treatment period, ii) the level of protection from severe malaria during the treatment period, iii) the effect on malaria morbidity after sustaining treatment, iv) the decrease of overall morbidity and mortality, including the number of hospital admissions and visits of hospital outpatient departments v) the influence of the intervention on the development of drug resistances, vi) the impact of the intervention on the development of immunity, vii) the possible influence of the intervention on sub-clinical organ dysfunction due to chronic Plasmodium falciparum infection. Parts of the study are performed in collaboration with the Laboratory of Research, Hospital Albert Schweitzer, Lambaréné, Gabon and the School of Medicine and Health Sciences, University of Development Studies, Tamale, Ghana

Conditions
Malaria, Anemia
Being tested
Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)
Keywords
Malaria, Anemia, IPTi, Intermittent Preventive Treatment in Infants, Sulfadoxine-Pyrimethamine, Chemoprophylaxis, 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.

  • Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)Drug

What is being measured

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

  1. • Efficacy of an extended intermittent treatment with sulfadoxine-pyrimethamine for the control of clinical malaria and anemia (proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 21 months of life)

  2. • Determination of the rate of clinical malaria and anemia after suspending an extended intermittent treatment for analysis of possible rebound effects

  3. • Evaluation of safety and adverse effects of the administration of single doses of sulfadoxine-pyrimethamine in infants and children

Secondary outcomes (7)

  1. • Rate and time points of hospitalizations with anemia, malaria or other diseases

  2. • Rate and time points of severe anemia episodes

  3. • Proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 12 months of life

  4. • Antibody responses against parasite antigens

  5. • Multiplicity of P. falciparum infections

  6. • Proportion of P. falciparum isolates with SP resistance

  7. • Influence of host genetic variants on the rate of P. falciparum infections

Timeline

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

  1. First posted21 Sep 2005 (estimated)
  2. Study startJan 2003
  3. Primary completionSep 2005
  4. Study completionSep 2005

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,070 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00206739
Sponsor's protocol ID
01KA0202-K7.3
Other IDs
01KA0202
Status last verified
Sep 2005
First submitted
13 Sep 2005
Last updated
30 Mar 2010
Results posted
No
Data monitoring committee
Yes

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 11377597

  • Menendez 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 9310602

  • Massaga 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

  • Verhoef H, West CE, Nzyuko SM, de Vogel S, van der Valk R, Wanga MA, Kuijsten A, Veenemans J, Kok FJ. Intermittent administration of iron and sulfadoxine-pyrimethamine to control anaemia in Kenyan children: a randomised controlled trial. Lancet. 2002 Sep 21;360(9337):908-14. doi: 10.1016/S0140-6736(02)11027-0.

    PubMed 12354473

  • May J, Adjei S, Busch W, Gabor JJ, Issifou S, Kobbe R, Kreuels B, Lell B, Schwarz NG, Adjei O, Kremsner PG, Grobusch MP. Therapeutic and prophylactic effect of intermittent preventive anti-malarial treatment in infants (IPTi) from Ghana and Gabon. Malar J. 2008 Oct 1;7:198. doi: 10.1186/1475-2875-7-198.

    PubMed 18828899

  • Kobbe R, Adjei S, Kreuzberg C, Kreuels B, Thompson B, Thompson PA, Marks F, Busch W, Tosun M, Schreiber N, Opoku E, Adjei O, Meyer CG, May J. Malaria incidence and efficacy of intermittent preventive treatment in infants (IPTi). Malar J. 2007 Dec 9;6:163. doi: 10.1186/1475-2875-6-163.

    PubMed 18067679

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg) in people with Malaria and Anemia, run by Bernhard Nocht Institute for Tropical Medicine at 1 site in Ghana.

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 4 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 30 Mar 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 Ghana. 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?

• Efficacy of an extended intermittent treatment with sulfadoxine-pyrimethamine for the control of clinical malaria and anemia (proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 21 months of life). 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 NCT00206739, which also lists 6 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 30 Mar 2010.

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