Etiology of Uncomplicated Fever in Children <5 in Rural Zanzibar (RDTNEG)

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

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.

Study Overview

• Status: Completed
• Conditions: Infectious Disease; Fever

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.

• Study Type: Observational
• Enrollment (Actual): 690

Contacts and Locations

Study Locations

• Tanzania
  • Zanzibar
    • Kivunge, Zanzibar, Tanzania
      • Facility: Primary health care center (PHCC), Kivunge, North A district, Zanzibar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Kivunge Primary Health Care Center (PHCC) in North A District in Zanzibar

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
relative frequency of febrile diseases etiology	Five months

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Göteborg University; World Health Organization; Zanzibar Malaria Control Programme; Queen Silvia Children's Hospital, Gothenburg, Sweden
• Investigators: Principal Investigator: Anders Björkman, Professor, Karolinska University Hopsital; Principal Investigator: Magnus Lindh, Professor, Sahlgrenska University Hospital, Gothenburg, Sweden; Principal Investigator: Mwinyi Msellem, MSc, Zanzibar Malaria Control Programme; Principal Investigator: Abdullah S. Ali, Manager, Zanzibar Malaria Control Programme; Principal Investigator: Birger Trollfors, Professor, Sahlgrenska University Hospital, Gothenburg, Sweden; Principal Investigator: Andreas Mårtensson, MD, PhD,, Karolinska University Hospital; Principal Investigator: Kristina Elfving, M.D., Sahlgrenska University Hospital, Gothenburg, Sweden; Principal Investigator: Delér Shakely, M.D., Karolinska University Hopsital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: March 26, 2010
• First Submitted That Met QC Criteria: March 26, 2010
• First Posted (Estimate): March 29, 2010

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Fever; Etiology; IMCI; Children under five years of age
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Body Temperature Changes; Infections; Communicable Diseases; Fever
• Other Study ID Numbers: Fever 2010