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

NCT00347113 | Completed

• 1 other identifier: TAN.5.2.SAF
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anaemia; Malaria; Hepatosplenomegaly

Keywords

P. falciparum; malaria; schistosome infections; soil-transmitted helminths infection; anaemia; immune response; Tanzania

Outcome Measures

Primary Outcomes (5)

• incidence of malaria cases

• Spleen and liver size

• Hæmoglobin

• P. falciparum specific antibodies (IgG3)

• Prevalence and intensity of schistosome anfd intestinal helminth infections

Interventions

Albendazole and praziquantel DRUG

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• DBL -Institute for Health Research and Development: lead

Study Sites (1)

Mwanza Medical Research Centre

Mwanza, Mwanza Region, PO. Box 1462, Tanzania

Location

MeSH Terms

Conditions

Anemia; Malaria

Interventions

Albendazole; Praziquantel

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isoquinolines

Study Officials

• Safari M Kinung'hi, Msc

  National Insitute for Medical Research, Mwanza, Tanzania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: July 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 23, 2014

Record last verified: 2011-01

Locations

TA (1)