An interventional study of Sulfadoxine-pyrimethamine (SP) + Artesunate (AS) in Malaria, sponsored by Hospital Clinic of Barcelona. Completed at 1 site in Mozambique. Open to participants aged Up to 1 Week, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-28.
Sponsored by Hospital Clinic of Barcelona · Not applicable and Interventional
The overall objective is to evaluate the effect of exposure to Plasmodium (P.) falciparum erythrocytic stage antigens during different periods of infancy on the development of naturally acquired immunity (NAI).
Hypothesis: Exposure to P. falciparum prior to 5 months of age does not result in the development of NAI, while exposure to P. falciparum after 5 months of age leads to the development of NAI. The risks of clinical malaria and anaemia during the second year of life will be compared between cohorts, as well as their correlations with the type and quality of immune responses (antibodies to several P. falciparum antigens, cytokines), oxidative stress markers and host genetic factors. These results should shed light on the determinants of the development of anti-P. falciparum responses early in life and the potential constraints to early life immunisation.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 349 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
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Inclusion Criteria:
Inclusion criteria for pregnant women:
Inclusion criteria for newborn infants:
Exclusion Criteria:
Exclusion criteria for pregnant women:
Exclusion criteria for newborn infants:
Participants received monthly Sulfadoxine-Pyrimethamine (SP) plus Artesunate (AS) from 2.5-4.5 months of age and monthly placebo from 5.5-9.5 months of age.
Drug: Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
Participants received monthly placebo from 2.5-4.5 months of age and monthly SP+AS from 5.5-9.5 months of age.
Drug: Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
Participants received monthly placebo from 2.5 to 9.5 months of age.
Drug: Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
Monthly chemoprophylaxis with SP (Fansidar® 500/25 mg) plus Artesunate (AS, Arsumax® 50 mg) or placebo (provided by Roche and Sanofi-Aventis) was administered according to the following age-based dosing schedule: ½ tablet of SP or placebo and ½ tablet of AS or placebo on the first day and ½ tablet of AS or placebo on the second and third days.
(Clinical) Time to first or only episode of clinical malaria in the second year of life detected by passive case detection
Global comparison between the 3 groups of the time to first or only episode of clinical malaria (according to the primary case definition) in the second year of follow up detected by passive case detection in the According-To-Protocol cohort. In addition, pairwise comparisons of the 3 groups are also presented.
Time frame: from 12 to 24 months of age
(Clinical) Time to first or only episode of malaria (using other case definitions), anaemia and other clinical endpoints.
Global comparison between the 3 study groups of the time to first or only episode of clinical malaria (according to the secondary case definitions) in the second year of follow up detected by passive case detection. Other endpoints include multiple episodes of malaria, time to first or only episode of anaemia, total hospital visits and prevalence of parasitaemia and anaemia at different time points. In addition, pairwise comparisons of the 3 groups are also presented.
Time frame: 12 to 24 months of age
Oxidative stress markers
Quantification of the antioxidant/pro-oxidant status over the first two years of life in relation to age of first exposure to infection.
Time frame: multiple time points during the first two years of life (2.5, 5.5, 10.5, 15 and 24 months of age)
Humoral and cellular immune responses
Quantification of antibody and cytokine responses to P. falciparum protein antigens and toxins over the first two years of life in relation to age of first exposure to infection
Time frame: multiple time points during the first two years of life (2.5, 5.5, 10.5, 15 and 24 months of age)
Host genetics
Analysis of haematological genetic factors, polymorphisms in genes involved in inflammatory or immunological responses to malaria and polymorphisms in genes involved in the Th1/Th2 immunological pathway.
Time frame: 2.5 months of age
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Hospital Clinic of Barcelona