Etiology of Uncomplicated Fever in Children <5 in Rural Zanzibar

Fever Clinical Trial

— RDTNEG  

Official title:

Infectious Disease Etiologies of Uncomplicated Febrile Illness in Children <5 Years of Age in Rural Zanzibar

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094431
• Other study ID #: Fever 2010
• Status: Completed
• Phase: N/A
• First received: March 26, 2010
• Last updated: December 2, 2014
• Start date: April 2011
• Est. completion date: July 2011

Study information

• Verified date: December 2014
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Regional Ethical Committee, Stockholm, Sweden:MOH Research Council, Zanzibar, Tanzania:
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to study the most common etiologies of uncomplicated fever diseases among children under five years of age in rural Zanzibar.

Description:

During the last 6 years Zanzibar has undergone a dramatic change in malaria epidemiology and burden of disease, with a marked decline of Plasmodium falciparum malaria among febrile children from approximately 30% to 1% or below and a reduction of crude child mortality of 50%. Millions of children in Africa die of neonatal disorders, acute respiratory tract infections (ARI), diarrhea, malaria, measles, HIV and malnutrition. A majority of these illnesses are also a common cause of febrile illness in out-patient departments. However, most of the few fever studies made in Africa are hospital based Very few studies on etiology of childhood febrile disease have been conducted on first level health facilities in the least developed countries in Africa. This study will therefore focus on children between 2 months to 5 years of age that have been diagnosed with a negative rapid diagnostic test (RDT) for malaria and their causes of fever at the first referral level in out-patient clinics in Zanzibar.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 59 Months

Eligibility

Inclusion Criteria:

• Patients between 2-59 months of age with confirmed fever, with a measured axillary temperature of =37.5°C, or history of fever within the preceding 24 hours.

• Presenting at the health facility from 8.00 to 16.00 Monday to Friday.

• Informed consent.

• Able and willing to complete stipulated follow-up.

Exclusion Criteria:

• Decision by the clinician to refer the patient to another health facility than the PHCC where the study is conducted.

• Symptoms/ signs of severe disease that requires immediate referral from the PHCC as defined by the clinicians. These symptoms/signs of severe disease are according to the IMCI guidelines.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Communicable Diseases
• Fever
• Infection
• Infectious Disease

Locations

Country	Name	City	State
Tanzania	Facility: Primary health care center (PHCC), Kivunge, North A district, Zanzibar	Kivunge	Zanzibar

Sponsors (5)

Lead Sponsor	Collaborator
Karolinska University Hospital	Göteborg University, Queen Silvia Children's Hospital, Gothenburg,. Sweden, World Health Organization, Zanzibar Malaria Control Programme

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative frequency of febrile diseases etiology		Five months	No