Ciprofloxacin during upper respiratory tract infections to reduce Pseudomonas aeruginosa infection in paediatric cystic fibrosis: a pilot study.
OBJECTIVE
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.
Southampton Children's Hospital, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, UK gary.connett@uhs.nhs.uk.
Gary J
GJ
Connett
National Institute for Health Research Southampton Respiratory Biomedical Research Unit, Southampton Children's Hospital and University Hospital Southampton NHS Foundation Trust, Southampton, UK Academic Unit of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Katharine C
KC
Pike
National Institute for Health Research Southampton Respiratory Biomedical Research Unit, Southampton Children's Hospital and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Julian P
JP
Legg
National Institute for Health Research Southampton Respiratory Biomedical Research Unit, Southampton Children's Hospital and University Hospital Southampton NHS Foundation Trust, Southampton, UK Academic Unit of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK Southampton NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Katrina
K
Cathie
Department of Paediatrics, Poole Hospital NHS Foundation Trust, Poole, UK.
Ann
A
Dewar
Department of Paediatrics, North Hampshire NHS Foundation Trust, Winchester, UK.
Keith
K
Foote
National Institute for Health Research Southampton Respiratory Biomedical Research Unit, Southampton Children's Hospital and University Hospital Southampton NHS Foundation Trust, Southampton, UKSouthampton NIHR Wellcome Trust Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Amanda
A
Harris
Southampton Children's Hospital and University Hospital Southampton NHS Foundation Trust Southampton, UK.
Saul N
SN
Faust
D000284:Administration, Oral; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D003550:Cystic Fibrosis / Q000150:complications* / Q000175:diagnosis / Q000382:microbiology / Q000821:virology; D004334:Drug Administration Schedule; D004739:England; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D010865:Pilot Projects; D011552:Pseudomonas Infections / Q000175:diagnosis / Q000382:microbiology / Q000517:prevention & control*; D011550:Pseudomonas aeruginosa / Q000187:drug effects* / Q000254:growth & development / Q000302:isolation & purification; D012141:Respiratory Tract Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology / Q000821:virology; D013997:Time Factors; D016896:Treatment Outcome; D014777:Virus Diseases / Q000150:complications* / Q000175:diagnosis / Q000821:virology
D000900:Anti-Bacterial Agents; D002939:Ciprofloxacin
Pseudomonas aeruginosa; ciprofloxacin; cystic fibrosis; randomized controlled trial