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Etiologies of Fever Among Adults in Dar es Salaam

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ClinicalTrials.gov Identifier: NCT01947075
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : August 21, 2014
Sponsor:
Collaborator:
Ifakara Health Institute
Information provided by (Responsible Party):
Valérie D'Acremont, Swiss Tropical & Public Health Institute

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Following the decline of malaria in Sub-Saharan Africa, clinicians face febrile patients in whom an alternative diagnosis has to be made. This situation has led to an overuse of antibiotics by clinicians. It is crucial to increase knowledge on etiologies and risk factors of outpatient febrile illness in order to improve their management.

This present proposal aims to investigate the etiologies of fever among adult patients attending an outpatient department in urban Tanzania. It also aims to assess the clinical significance of nasopharyngeal (NP) respiratory viruses and bacteria documentation in this setting. Third, it aims to compare the spectrum of infections in this population with that of children included in the same setting in a previous study. The last objective is to assess diabetes mellitus (DM) as a risk factor for infection and exposure to indoor air pollution (IAP) as a risk factor for acute respiratory infections (ARI) in adults in Tanzania.

The investigators hypothesize that acute respiratory infections are the main cause of adult febrile illness in a urban low-income setting and that use of quantitative molecular assays on naso-oropharyngeal samples can improve the diagnosis of pneumonia. The investigators also think that the spectrum of infections is different between children and adults, mainly due to a high HIV prevalence in adults. The investigators also hypothesize that experiencing IAP and/ or DM is a risk factor for infections in adults.


Condition or disease
Acute Febrile Illnesses

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 538 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Etiologies of Acute Febrile Illness Among Adults Attending an Outpatient Department in Dar es Salaam
Study Start Date : July 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Adults with fever
Every adult with fever will be screened for different infectious diseases and for nasopharyngeal respiratory viruses and bacteria
Healthy volonteers
For every adult with fever included with a diagnosis of pneumonia, a healthy volunteer will be included. These healthy volunteers will be screened for nasopharyngeal respiratory viruses and bacteria.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with each disease among all febrile patients, overall and stratified by HIV status [ Time Frame: 1 year ]
    Description of the distribution of causes of fever based on pre-defined case definitions for each disease.


Secondary Outcome Measures :
  1. Proportion of febrile patients with acute respiratory infection infected with a certain respiratory pathogen, compared to the proportion of healthy controls infected with the same pathogen. [ Time Frame: 1 year ]
    Nasopharyngeal respiratory viruses and bacteria documentation (presence/absence as well as pathogen loads) will be compared between patients with acute respiratory infection and a control group of healthy volunteers


Other Outcome Measures:
  1. Strength of association between each febrile disease and diabetes mellitus and between acute respiratory infections and indoor air pollution [ Time Frame: 1 year ]
    Screening of diabetes mellitus and screening of exposure to indoor air pollution will be performed among patients with fever. The strength of association between diabetes and each type of febrile disease and exposure to indoor air pollution and acute respiratory infections will be measured.


Biospecimen Retention:   Samples With DNA
Whole blood Serum Sputa Urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Every consecutive adult with temperature ≥38°C attending the outpatient department of Mwananyamala Hospital will be screened for inclusion. Additional inclusion criteria are fever of ≤1 week duration and first consultation for the present problem. Exclusion criteria are refusal of HIV screening, main complaint is injury or trauma, antibiotic treatment during the previous week (apart from cotrimoxazole prophylaxis), delivery within the previous 6 weeks and hospitalization during the last month. Medical history will be taken (including exposure to IAP) and clinical examination will be done in a standardized way.
Criteria

Inclusion Criteria:

  • Temperature >=38°C
  • History of fever for less than 8 days
  • First consultation for the present problem

Exclusion Criteria:

  • Refusal of HIV screening
  • Main complaint is injury or trauma
  • Antibiotic treatment in the last 7 days
  • Within 6 weeks after delivery
  • Hospitalization during the last month
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947075


Locations
Tanzania
Mwananyamala Hospital
Dar es Salaam, Tanzania
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Ifakara Health Institute
Investigators
Principal Investigator: Valerie D'Acremont, MD PhD Swiss Tropical & Public Health Institute
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Valérie D'Acremont, Investigator, Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT01947075     History of Changes
Other Study ID Numbers: Fever Study
Adult Fever Study ( Other Identifier: SwissTPH )
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014

Keywords provided by Valérie D'Acremont, Swiss Tropical & Public Health Institute:
Fever
Tanzania
Pneumonia
 HIV
Diabetes
Indoor Air Pollution

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms