FeverNCT02758821
The Impact of C-reactive Protein Testing
A study testing No CRP will be measured onsite, CRP cut-off of 20mg/L. and CRP cut-off of 40mg/L. in people with Fever, run by University of Oxford at 1 site in Thailand.
Trial summary
PRIMARY OBJECTIVE To assess the impact of C-reactive protein (CRP) Point-of-care (POC) testing on health care worker prescribing behaviour in patients presenting to primary healthcare centres with an acute fever or recent history of fever. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Fever
- What is being tested?
- No CRP will be measured onsite, CRP cut-off of 20mg/L. and CRP cut-off of 40mg/L.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,410 participants
- Where
- 1 siteThailand
- Study dates
- 8 Jun 2016to 30 Sep 2017
- Phase
- Interventional
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged ≥1 year presenting to selected primary healthcare centres
- Tympanic temperature >37.5°c or history of fever ≤ 14 days.
Who cannot join
- Patients that in view of the study nurse are in need of emergency referral to a higher-level facility, as indicated by either 1) impaired consciousness or 2) inability to take oral medication.
- In sites that routinely test for malaria, patients with a positive malaria rapid diagnostic test or microscopy will be excluded
- The main complaint is a trauma and/or injury
- Suspicion of tuberculosis (any medical history and/or physical examination suggesting tuberculosis)
- Suspicion of Urinary Tract Infections (any medical history and/or physical examination suggesting urinary tract infections)
- Suspicion of local skin/dental abscess (any medical history and/or physical examination suggesting a local skin/dental abscess
Show all 9Show fewer
- Any presenting symptom present for more than 14 days
- Bleeding, including otorrhagia, haematemesis, haemoptysis, haemorrhagic petechiae, haematuria, bloody diarrhoea.
- Not able to comply with the follow-up at Day 5 (+ / - 1 day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of C-reactive Protein Testing on Antibiotic Prescription in Febrile Patients Attending Primary Care in Low-resource Settings
PRIMARY OBJECTIVE To assess the impact of C-reactive protein (CRP) Point-of-care (POC) testing on health care worker prescribing behaviour in patients presenting to primary healthcare centres with an acute fever or recent history of fever.
SECONDARY OBJECTIVES To assess the impact of CRP testing on clinical outcomes within the 14 days of follow-up.
Read more
To assess the correlation between CRP results and clinical outcomes on the day 5 of the enrolment.
To estimate the impact of CRP testing on antibiotic consumption after first consultation.
To explore the attitudes of health centre staff towards the POC CRP test. To identify the prevalence of key pathogens in febrile patients in these settings.
To validate the ability of CRP to discriminate between viral and bacterial pathogens in a subset of patients with a microbiologically confirmed diagnosis.
Read the detailed description
This is a multi-centre, individually randomized-controlled, three-armed pragmatic trial comparing CRP guided antibiotic prescription in febrile patients to the current standard prescribing systems. The study will be implemented in low and middle-income countries in tropical settings, including Myanmar and Thailand in the first instance.
As participation in the study itself may raise awareness amongst the health centre staff and local community, current antibiotic prescribing rates will be assessed in an observational run-in period before the intervention. Health workers will be asked to complete case record forms (CRF) for patients presenting to their health centre with current or recent fever. This aims to capture current antibiotic prescribing habits before the study is launched.
During the intervention phase, patients fulfilling the inclusion criteria and who consent to participate in the study will be randomised to one of the three arms, as follows:
- Control group: The health care provider will manage the patient using standard guidelines. No CRP will be measured onsite
- Group A: CRP will be measured by a study nurse and the result will be communicated to the health care provider as "High-CRP" or "Low-CRP" using a low CRP cut-off of 20mg/L.
- Group B: CRP will be measured by a study nurse and the result will be communicated to the health care provider as "High-CRP" or "Low-CRP" using the higher CRP cut-off, of 40mg/L.
For the two intervention arms, the following guidance will be given to the health care provider: if the CRP test is reported as 'high', antibiotic treatment is recommended, following local guidelines, and if it is reported as 'low' antibiotics are not recommended. In either case the information provided by the CRP test should be interpreted alongside their clinical judgement.
A second CRP will be sampled at day 5 of the follow-up (+/- 1 day) for all the patients, using capillary blood from a finger prick.
The investigators will use the NycoCard Reader II (Axis Shield, Norway or equivalent) to measure CRP levels.
A venous blood sample and a nasopharyngeal swab will be taken in the control group at enrolment and sent to a central laboratory in order to detect the presence of the following key pathogens by real-time polymerase chain reaction (PCR):
- Flavivirus
- Alphavirus
- Influenza A \& B
- Rickettsia including typhus group and spotted fever group
- Leptospirosis
- PCR 16s for the detection of any bacteria.
- Malaria
CRP will also be retrospectively measured in these blood samples to validate its ability to distinguish between viral and bacterial infections.
A urine sample will be collected to detect the presence of antimicrobials at day 0 and day 5. This procedure will ascertain pre-study antibiotic intake, as well as the patient's compliance to the health care worker's prescription or advice that antibiotics are not required, during their participation in the study. The urine samples will be collected at the sites, divided into aliquots and frozen to -80°c to be stored on site. Monthly shipments will be made to the laboratory at Mahidol Oxford Tropical Research Medicine Unit in Thailand for analysis.
The investigators aim to follow-up every patient face to face on day 5 (+/-1 day), and either by phone or face-to-face interviews 14 days (+/-2 days) after the initial visit.
- Conditions
- Fever
- Being tested
- No CRP will be measured onsite, CRP cut-off of 20mg/L., CRP cut-off of 40mg/L.
- Keywords
- C-reactive protein, antibiotic
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No CRP will be measured onsiteOther
No CRP will be measured onsite
CRP cut-off of 20mg/L.Other
Health care worker will be given an advice to prescribe antibiotic to patient who has CRP lever < 20mg/L.
CRP cut-off of 40mg/L.Other
Health care worker will be given an advice to prescribe antibiotic to patient who has CRP lever < 40mg/L.
| Study group | Role | What they receive |
|---|---|---|
| CRP-Control | Other | The health care provider will manage the patient using standard guidelines. No CRP will be measured onsite Receives: Other: No CRP will be measured onsite |
| CRP-A | Other | CRP will be measured by a study nurse onsite and the result will be communicated to the health care provider. Receives: Other: CRP cut-off of 20mg/L. |
| CRP-B | Other | CRP will be measured by a study nurse onsite and the result will be communicated to the health care provider. Receives: Other: CRP cut-off of 40mg/L. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of recruited patients prescribed an antibiotic
The proportion of recruited patients prescribed an antibiotic at the health centre on or between their enrolment and the first follow-up visit (on day 5 +/- 1 day).
Measured: 6 Days
Secondary outcomes (14)
Duration of symptoms
Symptoms as defined by fever, any other symptom
Measured: 14 Days
Severity of symptoms
Severity will be assessed by the nurse using a rating scale graded from 1 to 4 (#Grading 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening), according to the patients' description of their symptoms, and the findings of the physical examination.
Measured: 14 Days
Frequency of severe clinical outcomes
as defined by admission to hospital or death within the 14 days of follow up
Measured: 14 Days
Proportion of patients that needed their clinical management changed within the 14 days of follow-up.
Measured: 14 Days
Frequency of unplanned re-consultation
Measured: 14 Days
Clinical outcome on Day 5 compare to CRP level
Measured: 5 Days
Proportion of patients with an immediate versus subsequent prescription within 2 weeks.
Measured: 14 Days
Proportion of urine samples that tested positive for presence of antibiotics
Measured: 14 Days
Interview of health centre staff for attitudes and satisfaction
Attitudes and satisfaction of health centre staff towards the CRP POC test
Measured: 6 months
The proportion of a population who have key pathogens
Key pathogens are Flavivirus, Alphavirus, Influenza A \& B, Rickettsia including typhus group and spotted fever group, Leptospirosis, PCR 16s for the detection of any bacteria and malaria
Measured: 6 months
Percentage of subjects who are correctly identified as having bacterial infections by using CRP testing
Sensitivity is defined as the proportion of patients with high CRP, out of all PCR confirmed bacterial infections.
Measured: 6 months
Percentage of subjects who are correctly identified as having viral infections by using CRP testing
Specificity is defined as the proportion of patients with low CRP, out of all PCR confirmed viral infections.
Measured: 6 months
The likelihood ratio (LR) of correctly identifying a bacterial infection by using CRP-testing.
The positive likelihood ratio is the fraction of sensitivity over (1 - Specificity) , and the negative likelihood ratio is the fraction of (1 - Sensitivity) over Specificity.
Measured: 6 months
The receiver operating characteristic (ROC) for evaluating the accuracy of CRP-testing in identifying bacterial infections.
We will use the ROC, or ROC curve, as a graphical plot, in order to illustrate the performance of the CRP-testing to classify bacterial and non-bacterial infections as its discrimination threshold is varied.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start8 Jun 2016
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Medical Research, Lower Myanmar
- Responsible party
- Sponsor
- Investigators
- Yoel Lubell, MD, Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758821
- Sponsor's protocol ID
- CRP POC
- Status last verified
- Aug 2018
- First submitted
- 10 Mar 2016
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Althaus T, Thaipadungpanit J, Greer RC, Swe MMM, Dittrich S, Peerawaranun P, Smit PW, Wangrangsimakul T, Blacksell S, Winchell JM, Diaz MH, Day NPJ, Smithuis F, Turner P, Lubell Y. Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens. Int J Infect Dis. 2020 Jul;96:334-342. doi: 10.1016/j.ijid.2020.05.016. Epub 2020 May 11.
PubMed 32437937Haenssgen MJ, Charoenboon N, Do NTT, Althaus T, Khine Zaw Y, Wertheim HFL, Lubell Y. How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions. Trials. 2019 Feb 8;20(1):111. doi: 10.1186/s13063-019-3215-9.
PubMed 30736818Althaus T, Greer RC, Swe MMM, Cohen J, Tun NN, Heaton J, Nedsuwan S, Intralawan D, Sumpradit N, Dittrich S, Doran Z, Waithira N, Thu HM, Win H, Thaipadungpanit J, Srilohasin P, Mukaka M, Smit PW, Charoenboon EN, Haenssgen MJ, Wangrangsimakul T, Blacksell S, Limmathurotsakul D, Day N, Smithuis F, Lubell Y. Effect of point-of-care C-reactive protein testing on antibiotic prescription in febrile patients attending primary care in Thailand and Myanmar: an open-label, randomised, controlled trial. Lancet Glob Health. 2019 Jan;7(1):e119-e131. doi: 10.1016/S2214-109X(18)30444-3.
PubMed 30554748
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of C-reactive Protein Testing on Antibiotic Prescription in Febrile Patients Attending Primary Care in Low-resource Settings
- ClinicalTrials.gov ID
- NCT02758821
- Acronym / sponsor ID
- CRP POC
- Conditions
- Fever
- Keywords
- C-reactive protein, antibiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,410 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Department of Medical Research, Lower Myanmar
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 3 May 2016 (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.
PRIMARY OBJECTIVE To assess the impact of C-reactive protein (CRP) Point-of-care (POC) testing on health care worker prescribing behaviour in patients presenting to primary healthcare centres with an acute fever or recent history of fever.
SECONDARY OBJECTIVES To assess the impact of CRP testing on clinical outcomes within the 14 days of follow-up.
To assess the correlation between CRP results and clinical outcomes on the day 5 of the enrolment.
To estimate the impact of CRP testing on antibiotic consumption after first consultation.
To explore the attitudes of health centre staff towards the POC CRP test. To identify the prevalence of key pathogens in febrile patients in these settings.
To validate the ability of CRP to discriminate between viral and bacterial pathogens in a subset of patients with a microbiologically confirmed diagnosis.
Detailed description
This is a multi-centre, individually randomized-controlled, three-armed pragmatic trial comparing CRP guided antibiotic prescription in febrile patients to the current standard prescribing systems. The study will be implemented in low and middle-income countries in tropical settings, including Myanmar and Thailand in the first instance.
As participation in the study itself may raise awareness amongst the health centre staff and local community, current antibiotic prescribing rates will be assessed in an observational run-in period before the intervention. Health workers will be asked to complete case record forms (CRF) for patients presenting to their health centre with current or recent fever. This aims to capture current antibiotic prescribing habits before the study is launched.
During the intervention phase, patients fulfilling the inclusion criteria and who consent to participate in the study will be randomised to one of the three arms, as follows:
- Control group: The health care provider will manage the patient using standard guidelines. No CRP will be measured onsite
- Group A: CRP will be measured by a study nurse and the result will be communicated to the health care provider as "High-CRP" or "Low-CRP" using a low CRP cut-off of 20mg/L.
- Group B: CRP will be measured by a study nurse and the result will be communicated to the health care provider as "High-CRP" or "Low-CRP" using the higher CRP cut-off, of 40mg/L.
For the two intervention arms, the following guidance will be given to the health care provider: if the CRP test is reported as 'high', antibiotic treatment is recommended, following local guidelines, and if it is reported as 'low' antibiotics are not recommended. In either case the information provided by the CRP test should be interpreted alongside their clinical judgement.
A second CRP will be sampled at day 5 of the follow-up (+/- 1 day) for all the patients, using capillary blood from a finger prick.
The investigators will use the NycoCard Reader II (Axis Shield, Norway or equivalent) to measure CRP levels.
A venous blood sample and a nasopharyngeal swab will be taken in the control group at enrolment and sent to a central laboratory in order to detect the presence of the following key pathogens by real-time polymerase chain reaction (PCR):
- Flavivirus
- Alphavirus
- Influenza A \& B
- Rickettsia including typhus group and spotted fever group
- Leptospirosis
- PCR 16s for the detection of any bacteria.
- Malaria
CRP will also be retrospectively measured in these blood samples to validate its ability to distinguish between viral and bacterial infections.
A urine sample will be collected to detect the presence of antimicrobials at day 0 and day 5. This procedure will ascertain pre-study antibiotic intake, as well as the patient's compliance to the health care worker's prescription or advice that antibiotics are not required, during their participation in the study. The urine samples will be collected at the sites, divided into aliquots and frozen to -80°c to be stored on site. Monthly shipments will be made to the laboratory at Mahidol Oxford Tropical Research Medicine Unit in Thailand for analysis.
The investigators aim to follow-up every patient face to face on day 5 (+/-1 day), and either by phone or face-to-face interviews 14 days (+/-2 days) after the initial visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRP-Control | Other | Other: No CRP will be measured onsiteThe health care provider will manage the patient using standard guidelines. No CRP will be measured onsite |
| CRP-A | Other | Other: CRP cut-off of 20mg/L.CRP will be measured by a study nurse onsite and the result will be communicated to the health care provider. |
| CRP-B | Other | Other: CRP cut-off of 40mg/L.CRP will be measured by a study nurse onsite and the result will be communicated to the health care provider. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥1 year presenting to selected primary healthcare centres
- Tympanic temperature >37.5°c or history of fever ≤ 14 days.
Key exclusion criteria (9 listed)
- Patients that in view of the study nurse are in need of emergency referral to a higher-level facility, as indicated by either 1) impaired consciousness or 2) inability to take oral medication.
- In sites that routinely test for malaria, patients with a positive malaria rapid diagnostic test or microscopy will be excluded
- The main complaint is a trauma and/or injury
- Suspicion of tuberculosis (any medical history and/or physical examination suggesting tuberculosis)
- Suspicion of Urinary Tract Infections (any medical history and/or physical examination suggesting urinary tract infections)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No CRP will be measured onsiteNo CRP will be measured onsite | Other | CRP-Control |
| CRP cut-off of 20mg/L.Health care worker will be given an advice to prescribe antibiotic to patient who has CRP lever < 20mg/L. | Other | CRP-A |
| CRP cut-off of 40mg/L.Health care worker will be given an advice to prescribe antibiotic to patient who has CRP lever < 40mg/L. | Other | CRP-B |
Primary outcome
The proportion of recruited patients prescribed an antibiotic
Time frame: 6 Days
The proportion of recruited patients prescribed an antibiotic at the health centre on or between their enrolment and the first follow-up visit (on day 5 +/- 1 day).
14 secondary outcomes
Duration of symptoms
Time frame: 14 Days
Severity of symptoms
Time frame: 14 Days
Frequency of severe clinical outcomes
Time frame: 14 Days
Proportion of patients that needed their clinical management changed within the 14 days of follow-up.
Time frame: 14 Days
Frequency of unplanned re-consultation
Time frame: 14 Days
Clinical outcome on Day 5 compare to CRP level
Time frame: 5 Days
Proportion of patients with an immediate versus subsequent prescription within 2 weeks.
Time frame: 14 Days
Proportion of urine samples that tested positive for presence of antibiotics
Time frame: 14 Days
Interview of health centre staff for attitudes and satisfaction
Time frame: 6 months
The proportion of a population who have key pathogens
Time frame: 6 months
Percentage of subjects who are correctly identified as having bacterial infections by using CRP testing
Time frame: 6 months
Percentage of subjects who are correctly identified as having viral infections by using CRP testing
Time frame: 6 months
The likelihood ratio (LR) of correctly identifying a bacterial infection by using CRP-testing.
Time frame: 6 months
The receiver operating characteristic (ROC) for evaluating the accuracy of CRP-testing in identifying bacterial infections.
Time frame: 6 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 15 Aug 2018.
- Derived from this study: PubMed 32437937Althaus T, Thaipadungpanit J, Greer RC, Swe MMM, Dittrich S, Peerawaranun P, Smit PW, Wangrangsimakul T, Blacksell S, Winchell JM, Diaz MH, Day NPJ, Smithuis F, Turner P, Lubell Y. Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens. Int J Infect Dis. 2020 Jul;96:334-342. doi: 10.1016/j.ijid.2020.05.016. Epub 2020 May 11.
- Derived from this study: PubMed 30736818Haenssgen MJ, Charoenboon N, Do NTT, Althaus T, Khine Zaw Y, Wertheim HFL, Lubell Y. How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions. Trials. 2019 Feb 8;20(1):111. doi: 10.1186/s13063-019-3215-9.
- Derived from this study: PubMed 30554748Althaus T, Greer RC, Swe MMM, Cohen J, Tun NN, Heaton J, Nedsuwan S, Intralawan D, Sumpradit N, Dittrich S, Doran Z, Waithira N, Thu HM, Win H, Thaipadungpanit J, Srilohasin P, Mukaka M, Smit PW, Charoenboon EN, Haenssgen MJ, Wangrangsimakul T, Blacksell S, Limmathurotsakul D, Day N, Smithuis F, Lubell Y. Effect of point-of-care C-reactive protein testing on antibiotic prescription in febrile patients attending primary care in Thailand and Myanmar: an open-label, randomised, controlled trial. Lancet Glob Health. 2019 Jan;7(1):e119-e131. doi: 10.1016/S2214-109X(18)30444-3.
- Individual participant dataSharing planned: No
Related trials for Fever
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
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.
Yoel Lubell, MD principal investigator
Mahidol Oxford Tropical Medicine Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No CRP will be measured onsite, CRP cut-off of 20mg/L. and CRP cut-off of 40mg/L. in people with Fever, run by University of Oxford at 1 site in Thailand.
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 2 inclusion and 9 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 15 Aug 2018. 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 Thailand. 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?
The proportion of recruited patients prescribed an antibiotic (time frame: 6 Days). 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 NCT02758821, which also lists 3 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 15 Aug 2018.