Acute Febrile IllnessesNCT01947075
Etiologies of Fever Among Adults in Dar es Salaam
An observational study of Acute Febrile Illnesses, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Febrile Illnesses
- How many people
- 538 participants
- Where
- 1 siteTanzania
- Study dates
- Jul 2013to Jul 2014
- How long will I take part?
- 30 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Temperature >=38°C
- History of fever for less than 8 days
- First consultation for the present problem
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etiologies of Acute Febrile Illness Among Adults Attending an Outpatient Department in Dar es Salaam
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.
- Conditions
- Acute Febrile Illnesses
- Keywords
- Fever, Tanzania, Pneumonia, HIV, Diabetes, Indoor Air Pollution
- Medical subject headings
- Fever, Pneumonia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with each disease among all febrile patients, overall and stratified by HIV status
Description of the distribution of causes of fever based on pre-defined case definitions for each disease.
Measured: 1 year
Secondary outcomes (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.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Febrile IllnessesStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 538 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ifakara Health Institute
- Responsible party
- Principal investigator, Valérie D'Acremont, Swiss Tropical & Public Health Institute
- Investigators
- Valerie D'Acremont, MD PhD, Principal investigator, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947075
- Sponsor's protocol ID
- Fever Study
- Other IDs
- Adult Fever Study
- Status last verified
- Aug 2014
- First submitted
- 13 Sep 2013
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Boillat-Blanco N, Klaassen B, Mbarack Z, Samaka J, Mlaganile T, Masimba J, Franco Narvaez L, Mamin A, Genton B, Kaiser L, D'Acremont V. Dengue fever in Dar es Salaam, Tanzania: clinical features and outcome in populations of black and non-black racial category. BMC Infect Dis. 2018 Dec 12;18(1):644. doi: 10.1186/s12879-018-3549-z.
PubMed 30541456Boillat-Blanco N, Mbarack Z, Samaka J, Mlaganile T, Mamin A, Genton B, Kaiser L, Calandra T, D'Acremont V. Prognostic value of quickSOFA as a predictor of 28-day mortality among febrile adult patients presenting to emergency departments in Dar es Salaam, Tanzania. PLoS One. 2018 Jun 14;13(6):e0197982. doi: 10.1371/journal.pone.0197982. eCollection 2018.
PubMed 29902174
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiologies of Acute Febrile Illness Among Adults Attending an Outpatient Department in Dar es Salaam
- ClinicalTrials.gov ID
- NCT01947075
- Acronym / sponsor ID
- Fever Study
- Conditions
- Acute Febrile Illnesses
- Keywords
- Fever, Tanzania, Pneumonia, HIV, Diabetes, Indoor Air Pollution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Ifakara Health Institute
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Sep 2013 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Temperature >=38°C
- History of fever for less than 8 days
- First consultation for the present problem
Key exclusion criteria (5 listed)
- 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
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
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.
1 secondary outcome
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
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 21 Aug 2014.
- Derived from this study: PubMed 30541456Boillat-Blanco N, Klaassen B, Mbarack Z, Samaka J, Mlaganile T, Masimba J, Franco Narvaez L, Mamin A, Genton B, Kaiser L, D'Acremont V. Dengue fever in Dar es Salaam, Tanzania: clinical features and outcome in populations of black and non-black racial category. BMC Infect Dis. 2018 Dec 12;18(1):644. doi: 10.1186/s12879-018-3549-z.
- Derived from this study: PubMed 29902174Boillat-Blanco N, Mbarack Z, Samaka J, Mlaganile T, Mamin A, Genton B, Kaiser L, Calandra T, D'Acremont V. Prognostic value of quickSOFA as a predictor of 28-day mortality among febrile adult patients presenting to emergency departments in Dar es Salaam, Tanzania. PLoS One. 2018 Jun 14;13(6):e0197982. doi: 10.1371/journal.pone.0197982. eCollection 2018.
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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.
Valerie D'Acremont, MD PhD principal investigator
Swiss Tropical & Public Health Institute
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 Acute Febrile Illnesses, run by Swiss Tropical & Public Health Institute 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 3 inclusion and 5 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 21 Aug 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?
Proportion of patients with each disease among all febrile patients, overall and stratified by HIV status (time frame: 1 year). 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 NCT01947075, which also lists 2 linked publications.
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 21 Aug 2014.