Etiologies of Fever Among Adults in Dar es Salaam

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Swiss Tropical & Public Health Institute
Sponsor:
Collaborator:
Ifakara Health Institute
Information provided by (Responsible Party):
Valérie D'Acremont, Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:
NCT01947075
First received: September 13, 2013
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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
Acute Febrile Illnesses

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Swiss Tropical & Public Health Institute:

Primary Outcome Measures:
  • Proportion of patients with each disease among all febrile patients, overall and stratified by HIV status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Description of the distribution of causes of fever based on pre-defined case definitions for each disease.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Strength of association between each febrile disease and diabetes mellitus and between acute respiratory infections and indoor air pollution [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 550
Study Start Date: July 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947075

Contacts
Contact: Noémie Boillat Blanco, MD +255 688037339 noemie.boillat@chuv.ch
Contact: Valérie D'Acremont, MD PhD 0041 79 2074355 Valerie.Dacremont@unibas.ch

Locations
Tanzania
Mwananyamala Hospital Recruiting
Dar es Salaam, Tanzania
Contact: Zainab Mbarak, MD    +255 717217771    bizainab@yahoo.com   
Contact: Mlinga Mbaruku, MD    +255 714214913    mubaj2002@yahoo.com   
Principal Investigator: Noémie Boillat Blanco, MD         
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

No publications provided

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
Study First Received: September 13, 2013
Last Updated: September 17, 2013
Health Authority: Tanzania: Ethical Committee

Keywords provided by Swiss Tropical & Public Health Institute:
Fever
Tanzania
Pneumonia
HIV
Diabetes
Indoor Air Pollution

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

ClinicalTrials.gov processed this record on July 29, 2014