Cargando…

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

BACKGROUND: Inappropriate antibiotic use for acute respiratory tract infections is common in primary health care, but distinguishing serious from self-limiting infections is difficult, particularly in low-resource settings. We assessed whether C-reactive protein point-of-care testing can safely redu...

Descripción completa

Detalles Bibliográficos
Autores principales: Do, Nga T T, Ta, Ngan T D, Tran, Ninh T H, Than, Hung M, Vu, Bich T N, Hoang, Long B, van Doorn, H Rogier, Vu, Dung T V, Cals, Jochen W L, Chandna, Arjun, Lubell, Yoel, Nadjm, Behzad, Thwaites, Guy, Wolbers, Marcel, Nguyen, Kinh V, Wertheim, Heiman F L
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Ltd 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4985565/
https://www.ncbi.nlm.nih.gov/pubmed/27495137
http://dx.doi.org/10.1016/S2214-109X(16)30142-5
_version_ 1782448078353072128
author Do, Nga T T
Ta, Ngan T D
Tran, Ninh T H
Than, Hung M
Vu, Bich T N
Hoang, Long B
van Doorn, H Rogier
Vu, Dung T V
Cals, Jochen W L
Chandna, Arjun
Lubell, Yoel
Nadjm, Behzad
Thwaites, Guy
Wolbers, Marcel
Nguyen, Kinh V
Wertheim, Heiman F L
author_facet Do, Nga T T
Ta, Ngan T D
Tran, Ninh T H
Than, Hung M
Vu, Bich T N
Hoang, Long B
van Doorn, H Rogier
Vu, Dung T V
Cals, Jochen W L
Chandna, Arjun
Lubell, Yoel
Nadjm, Behzad
Thwaites, Guy
Wolbers, Marcel
Nguyen, Kinh V
Wertheim, Heiman F L
author_sort Do, Nga T T
collection PubMed
description BACKGROUND: Inappropriate antibiotic use for acute respiratory tract infections is common in primary health care, but distinguishing serious from self-limiting infections is difficult, particularly in low-resource settings. We assessed whether C-reactive protein point-of-care testing can safely reduce antibiotic use in patients with non-severe acute respiratory tract infections in Vietnam. METHOD: We did a multicentre open-label randomised controlled trial in ten primary health-care centres in northern Vietnam. Patients aged 1–65 years with at least one focal and one systemic symptom of acute respiratory tract infection were assigned 1:1 to receive either C-reactive protein point-of-care testing or routine care, following which antibiotic prescribing decisions were made. Patients with severe acute respiratory tract infection were excluded. Enrolled patients were reassessed on day 3, 4, or 5, and on day 14 a structured telephone interview was done blind to the intervention. Randomised assignments were concealed from prescribers and patients but not masked as the test result was used to assist treatment decisions. The primary outcome was antibiotic use within 14 days of follow-up. All analyses were prespecified in the protocol and the statistical analysis plan. All analyses were done on the intention-to-treat population and the analysis of the primary endpoint was repeated in the per-protocol population. This trial is registered under number NCT01918579. FINDINGS: Between March 17, 2014, and July 3, 2015, 2037 patients (1028 children and 1009 adults) were enrolled and randomised. One adult patient withdrew immediately after randomisation. 1017 patients were assigned to receive C-reactive protein point-of-care testing, and 1019 patients were assigned to receive routine care. 115 patients in the C-reactive protein point-of-care group and 72 patients in the routine care group were excluded in the intention-to-treat analysis due to missing primary endpoint. The number of patients who used antibiotics within 14 days was 581 (64%) of 902 patients in the C-reactive protein group versus 738 (78%) of 947 patients in the control group (odds ratio [OR] 0·49, 95% CI 0·40–0·61; p<0·0001). Highly significant differences were seen in both children and adults, with substantial heterogeneity of the intervention effect across the 10 sites (I(2)=84%, 95% CI 66–96). 140 patients in the C-reactive protein group and 137 patients in the routine care group missed the urine test on day 3, 4, or 5. Antibiotic activity in urine on day 3, 4, or 5 was found in 267 (30%) of 877 patients in the C-reactive protein group versus 314 (36%) of 882 patients in the routine treatment group (OR 0·78, 95% CI 0·63–0·95; p=0·015). Time to resolution of symptoms was similar in both groups. Adverse events were rare, with no deaths and a total of 14 hospital admissions (six in the C-reactive protein group and eight in the control group). INTERPRETATION: C-reactive protein point-of-care testing reduced antibiotic use for non-severe acute respiratory tract infection without compromising patients' recovery in primary health care in Vietnam. Health-care providers might have become familiar with the clinical picture of low C-reactive protein, leading to reduction in antibiotic prescribing in both groups, but this would have led to a reduction in observed effect, rather than overestimation. Qualitative analysis is needed to address differences in context in order to implement this strategy to improve rational antibiotic use for patients with acute respiratory infection in low-income and middle-income countries. FUNDING: Wellcome Trust, UK, and Global Antibiotic Resistance Partnership, USA.
format Online
Article
Text
id pubmed-4985565
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher Elsevier Ltd
record_format MEDLINE/PubMed
spelling pubmed-49855652016-08-22 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 Do, Nga T T Ta, Ngan T D Tran, Ninh T H Than, Hung M Vu, Bich T N Hoang, Long B van Doorn, H Rogier Vu, Dung T V Cals, Jochen W L Chandna, Arjun Lubell, Yoel Nadjm, Behzad Thwaites, Guy Wolbers, Marcel Nguyen, Kinh V Wertheim, Heiman F L Lancet Glob Health Articles BACKGROUND: Inappropriate antibiotic use for acute respiratory tract infections is common in primary health care, but distinguishing serious from self-limiting infections is difficult, particularly in low-resource settings. We assessed whether C-reactive protein point-of-care testing can safely reduce antibiotic use in patients with non-severe acute respiratory tract infections in Vietnam. METHOD: We did a multicentre open-label randomised controlled trial in ten primary health-care centres in northern Vietnam. Patients aged 1–65 years with at least one focal and one systemic symptom of acute respiratory tract infection were assigned 1:1 to receive either C-reactive protein point-of-care testing or routine care, following which antibiotic prescribing decisions were made. Patients with severe acute respiratory tract infection were excluded. Enrolled patients were reassessed on day 3, 4, or 5, and on day 14 a structured telephone interview was done blind to the intervention. Randomised assignments were concealed from prescribers and patients but not masked as the test result was used to assist treatment decisions. The primary outcome was antibiotic use within 14 days of follow-up. All analyses were prespecified in the protocol and the statistical analysis plan. All analyses were done on the intention-to-treat population and the analysis of the primary endpoint was repeated in the per-protocol population. This trial is registered under number NCT01918579. FINDINGS: Between March 17, 2014, and July 3, 2015, 2037 patients (1028 children and 1009 adults) were enrolled and randomised. One adult patient withdrew immediately after randomisation. 1017 patients were assigned to receive C-reactive protein point-of-care testing, and 1019 patients were assigned to receive routine care. 115 patients in the C-reactive protein point-of-care group and 72 patients in the routine care group were excluded in the intention-to-treat analysis due to missing primary endpoint. The number of patients who used antibiotics within 14 days was 581 (64%) of 902 patients in the C-reactive protein group versus 738 (78%) of 947 patients in the control group (odds ratio [OR] 0·49, 95% CI 0·40–0·61; p<0·0001). Highly significant differences were seen in both children and adults, with substantial heterogeneity of the intervention effect across the 10 sites (I(2)=84%, 95% CI 66–96). 140 patients in the C-reactive protein group and 137 patients in the routine care group missed the urine test on day 3, 4, or 5. Antibiotic activity in urine on day 3, 4, or 5 was found in 267 (30%) of 877 patients in the C-reactive protein group versus 314 (36%) of 882 patients in the routine treatment group (OR 0·78, 95% CI 0·63–0·95; p=0·015). Time to resolution of symptoms was similar in both groups. Adverse events were rare, with no deaths and a total of 14 hospital admissions (six in the C-reactive protein group and eight in the control group). INTERPRETATION: C-reactive protein point-of-care testing reduced antibiotic use for non-severe acute respiratory tract infection without compromising patients' recovery in primary health care in Vietnam. Health-care providers might have become familiar with the clinical picture of low C-reactive protein, leading to reduction in antibiotic prescribing in both groups, but this would have led to a reduction in observed effect, rather than overestimation. Qualitative analysis is needed to address differences in context in order to implement this strategy to improve rational antibiotic use for patients with acute respiratory infection in low-income and middle-income countries. FUNDING: Wellcome Trust, UK, and Global Antibiotic Resistance Partnership, USA. Elsevier Ltd 2016-08-03 /pmc/articles/PMC4985565/ /pubmed/27495137 http://dx.doi.org/10.1016/S2214-109X(16)30142-5 Text en © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Articles
Do, Nga T T
Ta, Ngan T D
Tran, Ninh T H
Than, Hung M
Vu, Bich T N
Hoang, Long B
van Doorn, H Rogier
Vu, Dung T V
Cals, Jochen W L
Chandna, Arjun
Lubell, Yoel
Nadjm, Behzad
Thwaites, Guy
Wolbers, Marcel
Nguyen, Kinh V
Wertheim, Heiman F L
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4985565/
https://www.ncbi.nlm.nih.gov/pubmed/27495137
http://dx.doi.org/10.1016/S2214-109X(16)30142-5
work_keys_str_mv AT dongatt pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT tangantd pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT tranninhth pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT thanhungm pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT vubichtn pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT hoanglongb pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT vandoornhrogier pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT vudungtv pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT calsjochenwl pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT chandnaarjun pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT lubellyoel pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT nadjmbehzad pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT thwaitesguy pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT wolbersmarcel pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT nguyenkinhv pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial
AT wertheimheimanfl pointofcarecreactiveproteintestingtoreduceinappropriateuseofantibioticsfornonsevereacuterespiratoryinfectionsinvietnameseprimaryhealthcarearandomisedcontrolledtrial