C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting (CRP)
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
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Hanoi, Viêt Nam, 10000
- National Hospital for Tropical Diseases
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: CRP intervention
Patients will be tested by rapid POC CRP test
|
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.
|
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Aucune intervention: Control
Patients will not be tested by rapid POC CRP test
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of patients receiving any antibiotic
Délai: 2 weeks
|
Number of patients receiving any antibiotic within 2 weeks of study enrollment as a proportion of the total number of patients.
|
2 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Duration of symptoms
Délai: 2 weeks
|
Number of days that symptoms (including fever or any respiratory symptom) endure.
|
2 weeks
|
|
Frequency of re-consultation
Délai: 2 weeks
|
Number of visits to a health care practitioner during the 14 day follow-up.
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2 weeks
|
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Frequency of serious adverse events
Délai: 2 weeks
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Number of serious adverse events which occur during the 14 day follow-up period.
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2 weeks
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The attitudes and satisfaction of patients and health center staff towards the test.
Délai: 2 weeks
|
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 |
2 weeks
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Directeur d'études: Heiman FL Wertheim, M.D,Ph.D, Oxford University Clinical Research Unit
Publications et liens utiles
Publications générales
- 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.
- 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.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 05HN
Informations sur les médicaments et les dispositifs, documents d'étude
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