Clinical trial NCT01094431: Etiology of Uncomplicated Fever in Children <5 in Rural Zanzibar
Official title: Infectious Disease Etiologies of Uncomplicated Febrile Illness in Children <5 Years of Age in Rural Zanzibar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Infectious Disease
Keywords: Fever
Etiology
Children under five years of age
IMCI
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Zanzibar Malaria Control Programme
name: World Health Organization
name: Göteborg University
name: Queen Silvia Children's Hospital, Gothenburg, Sweden
First posted: 2010-03-29
Enrollment: 690
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kivunge Primary Health Care Center (PHCC) in North A District in Zanzibar

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: relative frequency of febrile diseases etiology
timeFrame: Five months
Secondary outcomes:
Other outcomes:
Locations:
city: Kivunge
country: Tanzania
facility: Facility: Primary health care center (PHCC), Kivunge, North A district, Zanzibar
state: Zanzibar
Study officials:
affiliation: Karolinska University Hopsital
name: Anders Björkman, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska University Hospital
name: Magnus Lindh, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zanzibar Malaria Control Programme
name: Mwinyi Msellem, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Zanzibar Malaria Control Programme
name: Abdullah S. Ali, Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska University Hospital
name: Birger Trollfors, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Andreas Mårtensson, MD, PhD,
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska University Hospital
name: Kristina Elfving, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hopsital
name: Deler Shakely, M.D.
role: PRINCIPAL_INVESTIGATOR
References: