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The efficacy and safety of a new ciprofloxacin suspension compared with co-amoxiclav tablets in the treatment of acute exacerbations of chronic bronchitis

The efficacy and safety of a new ciprofloxacin suspension compared with co-amoxiclav tablets in the treatment of acute exacerbations of chronic bronchitis
The efficacy and safety of a new ciprofloxacin suspension compared with co-amoxiclav tablets in the treatment of acute exacerbations of chronic bronchitis

A multinational, multicentre, randomized, prospective, parallel-group study compared treatment with ciprofloxacin administered as an oral suspension (500 mg twice daily for 7 days) with co-amoxiclav tablets (625 mg three times daily for 7 days) in patients suffering from acute exacerbations of chronic bronchitis (AECB). A total of 147 of 165 cases treated with ciprofloxacin (89.1%) and 146 of 162 cases treated with co-amoxiclav (90.1%) were classified as being clinical successes at the primary efficacy assessment 7 days after the end of therapy (assessed as reduced cough, improvement in dyspnoea, reduction in 24-h sputum volume or reduced purulence of sputum). Treatment equivalence was statistically confirmed; treatment difference:--1.0%, 95% CI--6.6% and 4.5%. Before treatment, 128 bacterial strains were isolated from 103 patients (60 ciprofloxacin and 68 co-amoxiclav). The most commonly isolated organism was Haemophilus influenzae (60 isolates), followed by Moraxella catarrhalis (12 isolates), Streptococcus pneumoniae (11 isolates) and Staphylococcus aureus (10 isolates). At day 14, 40 of 46 ciprofloxacin-treated patients (87.0%) and 46 of 55 co-amoxiclav-treated patients (83.6%) who were valid for bacteriological analysis were classified as being bacteriological success (classed as eradication, eradication with colonization or presumed eradication; treatment difference: 3.3%, 95% CI--8.3% and 14.9%). The adverse event profile was comparable between treatment groups. Most adverse events considered possibly or probably related to study drug were related to the gastrointestinal system and were of mild or moderate severity: nausea (13% ciprofloxacin, 10.6% co-amoxiclav), flatulence (10.3% ciprofloxacin, 3.9% co-amoxiclav), abdominal pain (7.6% ciprofloxacin, 7.3% co-amoxiclav) and diarrhoea (4.3% ciprofloxacin, 6.7% co-amoxiclav). We concluded that a 7-day course of ciprofloxacin suspension is equivalent to a 7-day course of co-amoxiclav tablets in terms of clinical and bacteriological efficacy and tolerability for the treatment of AECB. Thus, ciprofloxacin suspension may offer a suitable alternative treatment for AECB patients who have difficulty in swallowing, or who prefer liquid medications to tablets.

Acute Disease, Adolescent, Adult, Aged, Aged, 80 and over, Amoxicillin-Potassium Clavulanate Combination, Anti-Infective Agents, Bronchitis, Ciprofloxacin, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Prospective Studies, Tablets, Treatment Outcome, Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
0954-6111
252-261
Read, R.C.
b5caca7b-0063-438a-b703-7ecbb6fc2b51
Kuss, A.
a17259e3-ec48-4206-a27f-bd1bdf844a6d
Berrisoul, F.
0ed85691-c7ee-4e16-a8d2-c20ed26f4a7d
Kearsley, N.
c881aef3-6622-41b0-b757-4d681212cd15
Torres, A.
6f6cb97f-8162-440c-a426-b96f19ebd4a1
Kubin, R.
ad14f0a0-5ced-4795-a7c0-d15318a1d694
Read, R.C.
b5caca7b-0063-438a-b703-7ecbb6fc2b51
Kuss, A.
a17259e3-ec48-4206-a27f-bd1bdf844a6d
Berrisoul, F.
0ed85691-c7ee-4e16-a8d2-c20ed26f4a7d
Kearsley, N.
c881aef3-6622-41b0-b757-4d681212cd15
Torres, A.
6f6cb97f-8162-440c-a426-b96f19ebd4a1
Kubin, R.
ad14f0a0-5ced-4795-a7c0-d15318a1d694

Read, R.C., Kuss, A., Berrisoul, F., Kearsley, N., Torres, A. and Kubin, R. (1999) The efficacy and safety of a new ciprofloxacin suspension compared with co-amoxiclav tablets in the treatment of acute exacerbations of chronic bronchitis. Respiratory Medicine, 93 (4), 252-261.

Record type: Article

Abstract

A multinational, multicentre, randomized, prospective, parallel-group study compared treatment with ciprofloxacin administered as an oral suspension (500 mg twice daily for 7 days) with co-amoxiclav tablets (625 mg three times daily for 7 days) in patients suffering from acute exacerbations of chronic bronchitis (AECB). A total of 147 of 165 cases treated with ciprofloxacin (89.1%) and 146 of 162 cases treated with co-amoxiclav (90.1%) were classified as being clinical successes at the primary efficacy assessment 7 days after the end of therapy (assessed as reduced cough, improvement in dyspnoea, reduction in 24-h sputum volume or reduced purulence of sputum). Treatment equivalence was statistically confirmed; treatment difference:--1.0%, 95% CI--6.6% and 4.5%. Before treatment, 128 bacterial strains were isolated from 103 patients (60 ciprofloxacin and 68 co-amoxiclav). The most commonly isolated organism was Haemophilus influenzae (60 isolates), followed by Moraxella catarrhalis (12 isolates), Streptococcus pneumoniae (11 isolates) and Staphylococcus aureus (10 isolates). At day 14, 40 of 46 ciprofloxacin-treated patients (87.0%) and 46 of 55 co-amoxiclav-treated patients (83.6%) who were valid for bacteriological analysis were classified as being bacteriological success (classed as eradication, eradication with colonization or presumed eradication; treatment difference: 3.3%, 95% CI--8.3% and 14.9%). The adverse event profile was comparable between treatment groups. Most adverse events considered possibly or probably related to study drug were related to the gastrointestinal system and were of mild or moderate severity: nausea (13% ciprofloxacin, 10.6% co-amoxiclav), flatulence (10.3% ciprofloxacin, 3.9% co-amoxiclav), abdominal pain (7.6% ciprofloxacin, 7.3% co-amoxiclav) and diarrhoea (4.3% ciprofloxacin, 6.7% co-amoxiclav). We concluded that a 7-day course of ciprofloxacin suspension is equivalent to a 7-day course of co-amoxiclav tablets in terms of clinical and bacteriological efficacy and tolerability for the treatment of AECB. Thus, ciprofloxacin suspension may offer a suitable alternative treatment for AECB patients who have difficulty in swallowing, or who prefer liquid medications to tablets.

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More information

Published date: April 1999
Keywords: Acute Disease, Adolescent, Adult, Aged, Aged, 80 and over, Amoxicillin-Potassium Clavulanate Combination, Anti-Infective Agents, Bronchitis, Ciprofloxacin, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Prospective Studies, Tablets, Treatment Outcome, Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Identifiers

Local EPrints ID: 417322
URI: http://eprints.soton.ac.uk/id/eprint/417322
ISSN: 0954-6111
PURE UUID: 48516313-6573-4b53-8e44-0d081c1d7fc7
ORCID for R.C. Read: ORCID iD orcid.org/0000-0002-4297-6728

Catalogue record

Date deposited: 29 Jan 2018 17:30
Last modified: 10 Nov 2021 03:30

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Contributors

Author: R.C. Read ORCID iD
Author: A. Kuss
Author: F. Berrisoul
Author: N. Kearsley
Author: A. Torres
Author: R. Kubin

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