Intermittent Treatment With Sulfadoxine-pyrimethamine for Malaria Control in Infants

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206739
• Other study ID #: 01KA0202-K7.3
• Secondary ID: 01KA0202
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: March 29, 2010
• Start date: January 2003
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: Bernhard Nocht Institute for Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Ministry of Health
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1070
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 4 Months

Eligibility

Inclusion Criteria:

• Informed consent by parent/guardian (written or oral)

• Permanent residentship in the study area

• Age of 3 months +/-4 weeks

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Malaria

Intervention

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

Locations

Country	Name	City	State
Ghana	Kumasi Centre for Collaborative Research in Tropical Medicine	Kumasi	Ashanti Region

Sponsors (4)

Lead Sponsor	Collaborator
Bernhard Nocht Institute for Tropical Medicine	Deutscher Akademischer Austausch Dienst, German Federal Ministry of Education and Research, The Volkswagen Foundation

Country where clinical trial is conducted

Ghana, 

References & Publications (4)

Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Rønn 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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Lancet 2002 Oct 19;360(9341):1256. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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)
Primary	• Determination of the rate of clinical malaria and anemia after suspending an extended intermittent treatment for analysis of possible rebound effects
Primary	• Evaluation of safety and adverse effects of the administration of single doses of sulfadoxine-pyrimethamine in infants and children
Secondary	• Rate and time points of hospitalizations with anemia, malaria or other diseases
Secondary	• Rate and time points of severe anemia episodes
Secondary	• Proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 12 months of life
Secondary	• Antibody responses against parasite antigens
Secondary	• Multiplicity of P. falciparum infections
Secondary	• Proportion of P. falciparum isolates with SP resistance
Secondary	• Influence of host genetic variants on the rate of P. falciparum infections

External Links

•   Homepage of the Research Group Infection Epidemiology (co-ordination)