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

This study has been completed.
Sponsor:
Information provided by:
DBL -Institute for Health Research and Development
ClinicalTrials.gov Identifier:
NCT00347113
First received: June 30, 2006
Last updated: September 22, 2014
Last verified: January 2011
  Purpose

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.


Condition Intervention
Anaemia
Malaria
Hepatosplenomegaly
Drug: Albendazole and praziquantel

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

Resource links provided by NLM:


Further study details as provided by DBL -Institute for Health Research and Development:

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

Estimated Enrollment: 620
Study Start Date: July 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347113

Locations
Tanzania
Mwanza Medical Research Centre
Mwanza, Mwanza Region, Tanzania, PO. Box 1462
Sponsors and Collaborators
DBL -Institute for Health Research and Development
Investigators
Principal Investigator: Safari M Kinung'hi, Msc National Insitute for Medical Research, Mwanza, Tanzania
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00347113     History of Changes
Other Study ID Numbers: TAN.5.2.SAF
Study First Received: June 30, 2006
Last Updated: September 22, 2014
Health Authority: Tanzania: National Institute for Medical Research

Keywords provided by DBL -Institute for Health Research and Development:
P. falciparum
malaria
schistosome infections
soil-transmitted helminths infection
anaemia
immune response
Tanzania

Additional relevant MeSH terms:
Communicable Diseases
Infection
Malaria
Parasitic Diseases
Protozoan Infections
Praziquantel
Anthelmintics
Anti-Infective Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014