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Ciprofloxacin during upper respiratory tract infections to reduce Pseudomonas aeruginosa infection in paediatric cystic fibrosis: a pilot study

Ciprofloxacin during upper respiratory tract infections to reduce Pseudomonas aeruginosa infection in paediatric cystic fibrosis: a pilot study
Ciprofloxacin during upper respiratory tract infections to reduce Pseudomonas aeruginosa infection in paediatric cystic fibrosis: a pilot study

Objectives: Acute viral respiratory illnesses are associated with acquisition of Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients. This study aimed to pilot a protocol for a randomized controlled trial to determine whether oral antipseudomonal antibiotics used at the onset of such episodes might delay onset of infection with this organism.


Methods: A total of 41 children with CF aged 2–14 years, without chronic Pseudomonas infection, were randomized to receive ciprofloxacin (n = 28) or placebo (n = 13) at the onset of acute viral respiratory infections on an intention to treat basis, during a study period of up to 32 months.


Results: There were no unexpected adverse events believed related to the use of the study medication. The rate of withdrawal from the study was low (approximately 7%) and did not differ between groups. Randomization was effective and acceptable to participants. Primary and secondary outcome measures all favoured active treatment, but there were no significant between group differences. The median rate of Pseudomonas isolates was 0/patient/year (interquartile range 0–0.38) in both the active and placebo groups. Kaplan–Meier survival curves showed no significant difference in time to first Pseudomonas isolate between groups.


Conclusions: This study demonstrated the clinical feasibility of using oral ciprofloxacin in CF patients at times of viral infection. Within this sample size, no significant association was found between active treatment and decreased growth of Pseudomonas in follow-up microbiological samples. A definitive study would require at least 320 children to demonstrate significant differences in the rate of pseudomonal isolates.
1753-4658
Connett, G.J.
55d5676c-90d8-46bf-a508-62eded276516
Pike, K.C.
10be90c8-73de-416e-a2d0-0bb7e7276bd3
Legg, J.P.
6a4c913b-3672-4a67-947f-0e6817d23f12
Cathie, K.
ec8dd2eb-0be9-4567-b87d-72eadf5a254b
Dewar, A.
42af1005-8cdf-493c-90e3-2b543ca7a6ed
Foote, K.
3d4f0dc3-68ff-4f0b-b1d1-64a86436007e
Harris, A.
13bbc5ce-730a-4918-b751-296ea3d60bb3
Faust, S.N.
f97df780-9f9b-418e-b349-7adf63e150c1
Connett, G.J.
55d5676c-90d8-46bf-a508-62eded276516
Pike, K.C.
10be90c8-73de-416e-a2d0-0bb7e7276bd3
Legg, J.P.
6a4c913b-3672-4a67-947f-0e6817d23f12
Cathie, K.
ec8dd2eb-0be9-4567-b87d-72eadf5a254b
Dewar, A.
42af1005-8cdf-493c-90e3-2b543ca7a6ed
Foote, K.
3d4f0dc3-68ff-4f0b-b1d1-64a86436007e
Harris, A.
13bbc5ce-730a-4918-b751-296ea3d60bb3
Faust, S.N.
f97df780-9f9b-418e-b349-7adf63e150c1

Connett, G.J., Pike, K.C., Legg, J.P., Cathie, K., Dewar, A., Foote, K., Harris, A. and Faust, S.N. (2015) Ciprofloxacin during upper respiratory tract infections to reduce Pseudomonas aeruginosa infection in paediatric cystic fibrosis: a pilot study. Therapeutic Advances in Respiratory Disease. (doi:10.1177/1753465815601571).

Record type: Article

Abstract


Objectives: Acute viral respiratory illnesses are associated with acquisition of Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients. This study aimed to pilot a protocol for a randomized controlled trial to determine whether oral antipseudomonal antibiotics used at the onset of such episodes might delay onset of infection with this organism.


Methods: A total of 41 children with CF aged 2–14 years, without chronic Pseudomonas infection, were randomized to receive ciprofloxacin (n = 28) or placebo (n = 13) at the onset of acute viral respiratory infections on an intention to treat basis, during a study period of up to 32 months.


Results: There were no unexpected adverse events believed related to the use of the study medication. The rate of withdrawal from the study was low (approximately 7%) and did not differ between groups. Randomization was effective and acceptable to participants. Primary and secondary outcome measures all favoured active treatment, but there were no significant between group differences. The median rate of Pseudomonas isolates was 0/patient/year (interquartile range 0–0.38) in both the active and placebo groups. Kaplan–Meier survival curves showed no significant difference in time to first Pseudomonas isolate between groups.


Conclusions: This study demonstrated the clinical feasibility of using oral ciprofloxacin in CF patients at times of viral infection. Within this sample size, no significant association was found between active treatment and decreased growth of Pseudomonas in follow-up microbiological samples. A definitive study would require at least 320 children to demonstrate significant differences in the rate of pseudomonal isolates.

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e-pub ahead of print date: 4 September 2015
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 381428
URI: http://eprints.soton.ac.uk/id/eprint/381428
ISSN: 1753-4658
PURE UUID: 07b7a7e3-effd-4458-9dea-6332d3e4e36e
ORCID for G.J. Connett: ORCID iD orcid.org/0000-0003-1310-3239
ORCID for S.N. Faust: ORCID iD orcid.org/0000-0003-3410-7642

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Date deposited: 30 Sep 2015 16:26
Last modified: 18 Feb 2021 17:36

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Contributors

Author: G.J. Connett ORCID iD
Author: K.C. Pike
Author: J.P. Legg
Author: K. Cathie
Author: A. Dewar
Author: K. Foote
Author: A. Harris
Author: S.N. Faust ORCID iD

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