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Completed

NCT Number: NCT00687895

Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

General objective: To improve the quality of fever case management in children in government health facilities in Tanzania Hypothesis:The training of health workers, as well as provision, training and use of microscopes for malaria diagnosis will improve the treatment of clinical episodes of fever in children while reducing the amount and costs of drugs

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

dispensaries/health centers in Kibaha and Bagamoyo

Coast, Coast Region, Tanzania

About this study

PHC facilities were eligible for the study if they were rural government owned; accessible by road during rainy season; and within 3 hours by car from Muhimbili University College of Health Sciences (MUCHS), Dar es Salaam

All children attending the 16 PHC facilities under the study during daytime were enrolled if they fulfilled the following criteria:

  • below five years of age
  • fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
  • able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
  • the mother/guardian or caretaker consented to participate.

Patients with severe disease and/or general danger signs requiring inpatient care according to the IMCI guidelines were admitted or referred to the health centers or the district hospitals

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • below five years of age
  • fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days
  • able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur
  • the mother/guardian or caretaker consented to participate

Exclusion criteria

a) N/A

Treatment and study plan

Clinical algorithm and microscopy diagnosis of malaria

Procedure

Clinical alogarithm

The content of the package included

  • description of signs and symptoms of malaria disease
  • history taking relevant to malaria and physical examination
  • identification of danger signs and severe illness for referral
  • appropriate treatment
  • counseling patients on the use of drugs.

Malaria microscopy. contents

  • make thick blood smears from patients with fever and stain with Giemsa
  • identify and count malaria parasites
  • maintain the microscope and store blood slides.

Primary outcomes

  1. the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms

    Time frame: Day 0

Secondary outcomes

  1. prescriptions of antibiotics, cost of drugs

    Time frame: Day 0

  2. health outcome of the patients

    Time frame: Day 1-6, day 7

Sponsors and collaborators

Lead sponsor

Muhimbili University of Health and Allied Sciences

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Quality Malaria Case Management In Under- Fives In Primary Health Care (Phc) Institutions In Bagamoyo And Kibaha Districts Of Coastal Tanzania:a Multicomponent Controlled Intervention Study

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jun 2, 2008
Registry last updated
Jun 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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