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Article: Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination in the Treatment of Patients Hospitalized for Influenza A(H3N2) Infection: An Open-label Randomized, Controlled, Phase IIb/III Trial

TitleEfficacy of Clarithromycin-Naproxen-Oseltamivir Combination in the Treatment of Patients Hospitalized for Influenza A(H3N2) Infection: An Open-label Randomized, Controlled, Phase IIb/III Trial
Authors
KeywordsA(H3N2)
Clarithromycin
Hospitalized
Naproxen
Oseltamivir
Issue Date2017
PublisherElsevier, co-published with American College of Chest Physicians. The Journal's web site is located at http://www.chestjournal.org
Citation
Chest, 2017, v. 151 n. 5, p. 1069-1080 How to Cite?
AbstractBackground: Influenza causes excessive hospitalizations and deaths. The study assessed the efficacy and safety of a clarithromycin-naproxen-oseltamivir combination for treatment of serious influenza. Methods: From February to April 2015, we conducted a prospective open-label, randomized, controlled trial. Adult patients hospitalized for A(H3N2) influenza were randomly assigned to a 2-day combination of clarithromycin 500 mg, naproxen 200 mg, and oseltamivir 75 mg twice daily, followed by 3 days of oseltamivir or to oseltamivir 75 mg twice daily without placebo for 5 days as a control method (1:1). The primary end point was 30-day mortality. The secondary end points were 90-day mortality, serial nasopharyngeal aspirate (NPA) virus titer, percentage of neuraminidase-inhibitor-resistant A(H3N2) virus (NIRV) quasispecies, pneumonia severity index (PSI), and duration of hospital stay. Results: Among the 217 patients with influenza A(H3N2) enrolled, 107 were randomly assigned to the combination treatment. The median age was 80 years, and 53.5% were men. Adverse events were uncommon. Ten patients died during the 30-day follow-up. The combination treatment was associated with lower 30-day mortality (P = .01), less frequent high dependency unit admission (P = .009), and shorter hospital stay (P < .0001). The virus titer and PSI (days 1-3; P < .01) and the NPA specimens with NIRV quasispecies ≥ 5% (days 1-2; P < .01) were significantly lower in the combination treatment group. Multivariate analysis showed that combination treatment was the only independent factor associated with lower 30-day mortality (OR, 0.06; 95% CI, 0.004-0.94; P = .04). Conclusions: Combination treatment reduced both 30- and 90-day mortality and length of hospital stay. Further study of the antiviral and immunomodulatory effects of this combination treatment of severe influenza is warranted. Trial Registry: BioMed Central; No.: ISRCTN11273879 DOI 10.1186/ISRCTN11273879; URL: www.isrctn.com/ISRCTN11273879
Persistent Identifierhttp://hdl.handle.net/10722/243181
ISSN
2017 Impact Factor: 7.652
2015 SCImago Journal Rankings: 3.176
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorHung, FNI-
dc.contributor.authorTo, KKW-
dc.contributor.authorChan, JFW-
dc.contributor.authorCheng, CCV-
dc.contributor.authorLiu, SHK-
dc.contributor.authorTam, A-
dc.contributor.authorChan, TCI-
dc.contributor.authorZhang, J-
dc.contributor.authorLi, PCK-
dc.contributor.authorWong, TL-
dc.contributor.authorZhang, R-
dc.contributor.authorCheung, KSM-
dc.contributor.authorLeung, W-
dc.contributor.authorLau, JYN-
dc.contributor.authorFok, M-
dc.contributor.authorChen, H-
dc.contributor.authorChan, KH-
dc.contributor.authorYuen, KY-
dc.date.accessioned2017-08-25T02:51:14Z-
dc.date.available2017-08-25T02:51:14Z-
dc.date.issued2017-
dc.identifier.citationChest, 2017, v. 151 n. 5, p. 1069-1080-
dc.identifier.issn0012-3692-
dc.identifier.urihttp://hdl.handle.net/10722/243181-
dc.description.abstractBackground: Influenza causes excessive hospitalizations and deaths. The study assessed the efficacy and safety of a clarithromycin-naproxen-oseltamivir combination for treatment of serious influenza. Methods: From February to April 2015, we conducted a prospective open-label, randomized, controlled trial. Adult patients hospitalized for A(H3N2) influenza were randomly assigned to a 2-day combination of clarithromycin 500 mg, naproxen 200 mg, and oseltamivir 75 mg twice daily, followed by 3 days of oseltamivir or to oseltamivir 75 mg twice daily without placebo for 5 days as a control method (1:1). The primary end point was 30-day mortality. The secondary end points were 90-day mortality, serial nasopharyngeal aspirate (NPA) virus titer, percentage of neuraminidase-inhibitor-resistant A(H3N2) virus (NIRV) quasispecies, pneumonia severity index (PSI), and duration of hospital stay. Results: Among the 217 patients with influenza A(H3N2) enrolled, 107 were randomly assigned to the combination treatment. The median age was 80 years, and 53.5% were men. Adverse events were uncommon. Ten patients died during the 30-day follow-up. The combination treatment was associated with lower 30-day mortality (P = .01), less frequent high dependency unit admission (P = .009), and shorter hospital stay (P < .0001). The virus titer and PSI (days 1-3; P < .01) and the NPA specimens with NIRV quasispecies ≥ 5% (days 1-2; P < .01) were significantly lower in the combination treatment group. Multivariate analysis showed that combination treatment was the only independent factor associated with lower 30-day mortality (OR, 0.06; 95% CI, 0.004-0.94; P = .04). Conclusions: Combination treatment reduced both 30- and 90-day mortality and length of hospital stay. Further study of the antiviral and immunomodulatory effects of this combination treatment of severe influenza is warranted. Trial Registry: BioMed Central; No.: ISRCTN11273879 DOI 10.1186/ISRCTN11273879; URL: www.isrctn.com/ISRCTN11273879-
dc.languageeng-
dc.publisherElsevier, co-published with American College of Chest Physicians. The Journal's web site is located at http://www.chestjournal.org-
dc.relation.ispartofChest-
dc.subjectA(H3N2)-
dc.subjectClarithromycin-
dc.subjectHospitalized-
dc.subjectNaproxen-
dc.subjectOseltamivir-
dc.titleEfficacy of Clarithromycin-Naproxen-Oseltamivir Combination in the Treatment of Patients Hospitalized for Influenza A(H3N2) Infection: An Open-label Randomized, Controlled, Phase IIb/III Trial-
dc.typeArticle-
dc.identifier.emailHung, FNI: ivanhung@hkucc.hku.hk-
dc.identifier.emailTo, KKW: kelvinto@hkucc.hku.hk-
dc.identifier.emailChan, JFW: jfwchan@hku.hk-
dc.identifier.emailCheng, CCV: vcccheng@hkucc.hku.hk-
dc.identifier.emailLiu, SHK: drkliu@hku.hk-
dc.identifier.emailChan, TCI: tuenchin@hku.hk-
dc.identifier.emailZhang, J: zhangajx@hkucc.hku.hk-
dc.identifier.emailLi, PCK: drckli@hku.hk-
dc.identifier.emailCheung, KSM: cks634@hku.hk-
dc.identifier.emailChen, H: hlchen@hku.hk-
dc.identifier.emailChan, KH: chankh2@hkucc.hku.hk-
dc.identifier.emailYuen, KY: kyyuen@hkucc.hku.hk-
dc.identifier.authorityHung, FNI=rp00508-
dc.identifier.authorityTo, KKW=rp01384-
dc.identifier.authorityChan, JFW=rp01736-
dc.identifier.authorityZhang, J=rp00413-
dc.identifier.authorityCheung, KSM=rp02532-
dc.identifier.authorityChen, H=rp00383-
dc.identifier.authorityChan, KH=rp01921-
dc.identifier.authorityYuen, KY=rp00366-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/j.chest.2016.11.012-
dc.identifier.pmid27884765-
dc.identifier.scopuseid_2-s2.0-85019156178-
dc.identifier.hkuros275459-
dc.identifier.volume151-
dc.identifier.issue5-
dc.identifier.spage1069-
dc.identifier.epage1080-
dc.identifier.isiWOS:000402798000025-
dc.publisher.placeUnited States-

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