## Protocol Section
### Identification Module
**NCT ID:** NCT01918579

**Acronym:** CRP

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 05HN
#### Organization
**Class:** OTHER
**Full Name:** Oxford University Clinical Research Unit, Vietnam
### Status Module
#### Completion Date
**Date:** 2015-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-11-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-11-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-07

**Type:** ACTUAL

#### Start Date
**Date:** 2014-03

**Status Verified Date:** 2014-06

#### Study First Post Date
**Date:** 2013-08-07
**Type:** ESTIMATED
**Study First Submit Date:** 2013-08-06
**Study First Submit QC Date:** 2013-08-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** National Hospital for Tropical Diseases, Hanoi, Vietnam

#### Lead Sponsor

**Class:** OTHER

**Name:** Oxford University Clinical Research Unit, Vietnam

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Acute Respiratory Infections

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 2037

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will be tested by rapid POC CRP test

**Intervention Names:**

- Procedure: Patients will be tested by rapid POC CRP test

**Label:** CRP intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients will not be tested by rapid POC CRP test

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CRP intervention

**Description:** Patient will be tested with CRP test. Treatment decisions including any antibiotics prescribed will be based on test results and clinical judgement. Treatment choices are not recommended/prescribed by the study protocol.

**Name:** Patients will be tested by rapid POC CRP test

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** Patients and health center staff will be interviewed by structured questionnaire to assess their attitudes and satisfaction toward the intervention.

The Likert scale will be used for quantifying attitude orientation of interviewees

**Measure:** The attitudes and satisfaction of patients and health center staff towards the test.

**Time Frame:** 2 weeks

#### Primary Outcomes

**Description:** Number of patients receiving any antibiotic within 2 weeks of study enrollment as a proportion of the total number of patients.

**Measure:** Proportion of patients receiving any antibiotic

**Time Frame:** 2 weeks

#### Secondary Outcomes

**Description:** Number of days that symptoms (including fever or any respiratory symptom) endure.

**Measure:** Duration of symptoms

**Time Frame:** 2 weeks

**Description:** Number of visits to a health care practitioner during the 14 day follow-up.

**Measure:** Frequency of re-consultation

**Time Frame:** 2 weeks

**Description:** Number of serious adverse events which occur during the 14 day follow-up period.

**Measure:** Frequency of serious adverse events

**Time Frame:** 2 weeks

### Eligibility Module

**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.

**Maximum Age:** 65 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hanoi

**Country:** Vietnam

**Facility:** National Hospital for Tropical Diseases

**Zip:** 10000

#### Overall Officials

**Official 1:**

**Affiliation:** Oxford University Clinical Research Unit

**Name:** Heiman FL Wertheim, M.D,Ph.D

**Role:** STUDY_DIRECTOR

### References Module

#### 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.

**PMID:** 30736818

**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. Erratum In: Lancet Glob Health. 2017 Jan;5(1):e39.

**PMID:** 27495137

#### See Also Links

**Label:** Oxford University Clinical Research Unit, Viet Nam

**URL:** http://www.oucru.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: HIGH

- As Found: Respiratory Infection

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000012141

- Term: Respiratory Tract Infections

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
