Schistosome and Intestinal Worm Infections and Malaria Morbidity Among School and Pre-school Children in, Tanzania
Primary Purpose
Anaemia, Malaria, Hepatosplenomegaly
Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Albendazole and praziquantel
Sponsored by
About this trial
This is an interventional prevention trial for Anaemia focused on measuring P. falciparum, malaria, schistosome infections, soil-transmitted helminths infection, anaemia, immune response, Tanzania
Eligibility Criteria
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)
Sites / Locations
- Mwanza Medical Research Centre
Outcomes
Primary Outcome Measures
incidence of malaria cases
Spleen and liver size
Hæmoglobin
P. falciparum specific antibodies (IgG3)
Prevalence and intensity of schistosome anfd intestinal helminth infections
Secondary Outcome Measures
Full Information
NCT ID
NCT00347113
First Posted
June 30, 2006
Last Updated
September 22, 2014
Sponsor
DBL -Institute for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00347113
Brief Title
Schistosome and Intestinal Worm Infections and Malaria Morbidity Among School and Pre-school Children in, Tanzania
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
DBL -Institute for Health Research and Development
4. Oversight
5. Study Description
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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaemia, Malaria, Hepatosplenomegaly
Keywords
P. falciparum, malaria, schistosome infections, soil-transmitted helminths infection, anaemia, immune response, Tanzania
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
620 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Albendazole and praziquantel
Primary Outcome Measure Information:
Title
incidence of malaria cases
Title
Spleen and liver size
Title
Hæmoglobin
Title
P. falciparum specific antibodies (IgG3)
Title
Prevalence and intensity of schistosome anfd intestinal helminth infections
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Safari M Kinung'hi, Msc
Organizational Affiliation
National Insitute for Medical Research, Mwanza, Tanzania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mwanza Medical Research Centre
City
Mwanza
State/Province
Mwanza Region
ZIP/Postal Code
PO. Box 1462
Country
Tanzania
12. IPD Sharing Statement
Learn more about this trial
Schistosome and Intestinal Worm Infections and Malaria Morbidity Among School and Pre-school Children in, Tanzania
We'll reach out to this number within 24 hrs