Clinical trial NCT01918579: C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting
Official title: Efficacy of Point-of-care (POC) C-reactive Protein Testing to Reduce Inappropriate Use of Antibiotics for Acute Respiratory Infections (ARIs) in the Primary Health Care Setting of Hanoi - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Infections
Lead sponsor: Oxford University Clinical Research Unit, Vietnam
Sponsor class: OTHER
Collaborators: name: National Hospital for Tropical Diseases, Hanoi, Vietnam
First posted: 2013-08-07
Enrollment: 2037
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Many studies have showed that rapid point-of-care (POC) c-reactive protein (CRP) test can reduce inappropriate use of antibiotic at primary health care level. In Vietnam, prevalence of antibiotic abuse for community acute respiratory infection has been reported. This study will test the hypothesis that CRP POC testing for patients with non-severe acute respiratory illness at primary healthcare stations reduces inappropriate antibiotic use safely.

The study will be conducted at ten district health care facilities in Hanoi, Viet Nam. Investigators intend to enroll 2,000 participants aged 6-65 years with non-severe acute respiratory infection. Patients will be randomly allocated to the control or the intervention arm. Participants in the control group will be treated according to routine care. Participants in the intervention arm will have a CRP test, the results of which will be available to the health care practitioner to contribute to their diagnosis and treatment decisions.

All patients will be followed-up via telephone call after 14 days. The study will compare the proportion of patients in each arm receiving any antibiotics within 2 weeks of study enrollment.


Eligibility criteria: Inclusion Criteria:

* Patients, aged 6 to 65 years, that visit one of the 10 selected primary healthcare centers
* Suspected to have acute respiratory tract infection (ARI) by treating physician
* Informed consent

Exclusion Criteria:

* Severe respiratory disease as determined by treating doctor
* Any disease or symptom requiring hospital referral as determined by treating doctor
* Immunosuppressed patients (e.g. HIV, long term steroid use)
* Suspicion of tuberculosis
* Evidence of acute or chronic liver disease (e.g. hepatitis or cirrhosis due to any cause)
* Past medical history of: neoplastic disease, congestive cardiac failure, chronic obstructive pulmonary disease, insulin-dependent diabetes or renal disease
* Pregnancy
* No access to telephone
* Not able to come for follow up visit on day 3 or 4.
* Already taking antibiotics at the time of presentation
* Symptoms present for more than 2 weeks
* Presence of any sign of severe diseases as defined by the British Thoracic Society modified CRP-65 system for severity scoring of pneumonia in primary care.

For children (Age ≥ 6 years and \< 16 years) additional exclusion criteria include: Tachypnea, signs of chest wall in drawing, reduced consciousness, confusion, dehydration, hypothermia, severe malnutrition, unable to feed or drink, vomiting, and convulsions.

Primary outcomes:
measure: Proportion of patients receiving any antibiotic
timeFrame: 2 weeks
Secondary outcomes:
measure: Duration of symptoms
timeFrame: 2 weeks
measure: Frequency of re-consultation
timeFrame: 2 weeks
measure: Frequency of serious adverse events
timeFrame: 2 weeks
Other outcomes:
measure: The attitudes and satisfaction of patients and health center staff towards the test.
timeFrame: 2 weeks
Locations:
city: Hanoi
country: Vietnam
facility: National Hospital for Tropical Diseases
Study officials:
affiliation: Oxford University Clinical Research Unit
name: Heiman FL Wertheim, M.D,Ph.D
role: STUDY_DIRECTOR
References:
citation: Haenssgen 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.
citation: Do NT, Ta NT, Tran NT, Than HM, Vu BT, Hoang LB, van Doorn HR, Vu DT, Cals JW, Chandna A, Lubell Y, Nadjm B, Thwaites G, Wolbers M, Nguyen KV, Wertheim HF. Point-of-care C-reactive protein testing to reduce inappropriate use of antibiotics for non-severe acute respiratory infections in Vietnamese primary health care: a randomised controlled trial. Lancet Glob Health. 2016 Sep;4(9):e633-41. doi: 10.1016/S2214-109X(16)30142-5. Epub 2016 Aug 3.