FeverRDTNEGNCT01094431
Etiology of Uncomplicated Fever in Children <5 in Rural Zanzibar
An observational study of Fever and Infectious Disease, run by Karolinska University Hospital at 1 site in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Fever, Infectious Disease
- How many people
- 690 participants
- Where
- 1 siteTanzania
- Study dates
- Apr 2011to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 59 months
- All sexes
- No healthy volunteers
- Child
Study population: Kivunge Primary Health Care Center (PHCC) in North A District in Zanzibar
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Facility: Primary health care center (PHCC), Kivunge, North A district, Zanzibar
Kivunge, Zanzibar
About this study
Official title: 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.
Read the 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.
- Conditions
- Fever, Infectious Disease
- Keywords
- Fever, Etiology, Children under five years of age, IMCI
- Medical subject headings
- Fever, Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
relative frequency of febrile diseases etiology
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startApr 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zanzibar Malaria Control Programme, World Health Organization, Göteborg University, Queen Silvia Children's Hospital, Gothenburg, Sweden
- Responsible party
- Principal investigator, Anders Björkman, Karolinska University Hospital
- Investigators
- Anders Björkman, Professor, Principal investigator, Karolinska University HopsitalMagnus Lindh, Professor, Principal investigator, Sahlgrenska University HospitalMwinyi Msellem, MSc, Principal investigator, Zanzibar Malaria Control ProgrammeAbdullah S. Ali, Manager, Principal investigator, Zanzibar Malaria Control ProgrammeBirger Trollfors, Professor, Principal investigator, Sahlgrenska University HospitalAndreas Mårtensson, MD, PhD,, Principal investigator, Karolinska University HospitalKristina Elfving, M.D., Principal investigator, Sahlgrenska University HospitalDeler Shakely, M.D., Principal investigator, Karolinska University Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094431
- Sponsor's protocol ID
- Fever 2010
- Acronym
- RDTNEG
- Status last verified
- Dec 2014
- First submitted
- 26 Mar 2010
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elfving K, Stromberg LG, Geravandi S, Andersson M, Bachelard M, Msellem M, Shakely D, Trollfors B, Norden R, Martensson A, Bjorkman A, Lindh M. Pneumococcal concentration and serotype distribution in preschool children with radiologically confirmed pneumonia compared to healthy controls prior to introduction of pneumococcal vaccination in Zanzibar: an observational study. BMC Infect Dis. 2022 Dec 10;22(1):925. doi: 10.1186/s12879-022-07902-5.
PubMed 36496395
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infectious Disease Etiologies of Uncomplicated Febrile Illness in Children <5 Years of Age in Rural Zanzibar
- ClinicalTrials.gov ID
- NCT01094431
- Acronym / sponsor ID
- RDTNEG / Fever 2010
- Conditions
- Fever, Infectious Disease
- Keywords
- Fever, Etiology, Children under five years of age, IMCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Zanzibar Malaria Control Programme, World Health Organization, Göteborg University, Queen Silvia Children's Hospital, Gothenburg, Sweden
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Kivunge Primary Health Care Center (PHCC) in North A District in Zanzibar
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
relative frequency of febrile diseases etiology
Time frame: Five months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 36496395Elfving K, Stromberg LG, Geravandi S, Andersson M, Bachelard M, Msellem M, Shakely D, Trollfors B, Norden R, Martensson A, Bjorkman A, Lindh M. Pneumococcal concentration and serotype distribution in preschool children with radiologically confirmed pneumonia compared to healthy controls prior to introduction of pneumococcal vaccination in Zanzibar: an observational study. BMC Infect Dis. 2022 Dec 10;22(1):925. doi: 10.1186/s12879-022-07902-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Björkman, Professor principal investigator
Karolinska University Hopsital
Magnus Lindh, Professor principal investigator
Sahlgrenska University Hospital
Mwinyi Msellem, MSc principal investigator
Zanzibar Malaria Control Programme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever and Infectious Disease, run by Karolinska University Hospital at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative frequency of febrile diseases etiology (time frame: Five months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01094431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.