Schistosome and Intestinal Worm Infections and Malaria Morbidity Among School and Pre-school Children in, Tanzania

Malaria Clinical Trial

Official title:

The Effect of Schistosome and Soil-transmitted Helminth Infections on Malaria,Infection, Morbidity and Antibody Response Among School and Pre-school Children in Mwanza, Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347113
• Other study ID #: TAN.5.2.SAF
• Status: Completed
• Phase: N/A
• First received: June 30, 2006
• Last updated: September 22, 2014
• Start date: July 2006
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: DBL -Institute for Health Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial Summary

The proposed study has as the main objective to investigate the effect of schistosome and STH infections and the effect of an anthelminthic intervention on P. falciparum malaria, related anaemia and malaria antibody responses among school and pre-school children in Mwanza, Tanzania. The study will include a cross-sectional baseline survey followed by an anthelminthic intervention trial of two years duration. At baseline, prevalence and intensity of malaria, schistosome and STH infections and the prevalence of anaemia will be determined by examination of blood, faecal and urine samples. Spleen and liver size and consistency will be determined by palpation. P. falciparum specific antibodies will be determined by ELISA. All children will be treated with a single dose of praziquantel 40mg/kg and albendazole 400mg. Children selected to participate in the intervention trial will be randomized into two groups, an intervention group of 258 children which will be followed up with albendazole 400mg and praziquantel 40mg/kg at three months interval and a control group of 258 children which will be followed up with praziquantel 40mg/kg and albendazole 400mg once a year in accordance with the National Schistosomiasis and Soil-transmitted Helminths Control Programme. At 12 months and 24 months follow-up, all examinations conducted at baseline survey will be repeated.

Description:

alaria is a major public health problem in tropical and subtropical countries particularly sub-Saharan Africa. Studies have shown that in Tanzania malaria, schistosome and soil-transmitted helminth infections (STH) (Hookworms, Ascaris lumbricoides and Trichuris trichiura) are co-endemic and that they share the human hosts. It has been hypothesized that co-infection with schistosomes and STH may modulate the immune response to Plasmodium falciparum leading to increased susceptibility to clinical malaria and severity of cases. The proposed study has as the main objective to investigate the effect of schistosome and STH infections and the effect of an anthelminthic intervention on P. falciparum malaria, related anaemia and malaria antibody responses among school and pre-school children in Mwanza, Tanzania. The study will include a cross-sectional baseline survey followed by an anthelminthic intervention trial of two years duration. At baseline, prevalence and intensity of malaria, schistosome and STH infections and the prevalence of anaemia will be determined by examination of blood, faecal and urine samples. Spleen and liver size and consistency will be determined by palpation. P. falciparum specific antibodies will be determined by ELISA. All children will be treated with a single dose of praziquantel 40mg/kg and albendazole 400mg. Children selected to participate in the intervention trial will be randomized into two groups, an intervention group of 258 children which will be followed up with albendazole 400mg and praziquantel 40mg/kg at three months interval and a control group of 258 children which will be followed up with praziquantel 40mg/kg and albendazole 400mg once a year in accordance with the National Schistosomiasis and Soil-transmitted Helminths Control Programme. At 12 months and 24 months follow-up, all examinations conducted at baseline survey will be repeated. If an effect of schistosome and STH infections on malaria infection and morbidity is demonstrated, control of these diseases could provide another feasible and affordable way of reducing malaria morbidity. Results of the proposed study will contribute to the understanding of the epidemiology and control of malaria in the context of other co-endemic diseases and may be important in the planning of integrated disease control strategies.

Keywords: P. falciparum, malaria, schistosome infections, soil-transmitted helminths infection, anaemia, immune response, Tanzania

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• preschool children (>5 years of age) school children standard I-V (>7 years of age

Exclusion Criteria:

• Children with severe malaria or anaemia Children who have receuived anthelmintic treatment (< 6 months ago)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anaemia
• Hepatosplenomegaly
• Malaria

Intervention

Drug:
• Albendazole and praziquantel

Locations

Country	Name	City	State
Tanzania	Mwanza Medical Research Centre	Mwanza	Mwanza Region

Sponsors (1)

Lead Sponsor	Collaborator
DBL -Institute for Health Research and Development

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of malaria cases
Primary	Spleen and liver size
Primary	Hæmoglobin
Primary	P. falciparum specific antibodies (IgG3)
Primary	Prevalence and intensity of schistosome anfd intestinal helminth infections