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Clinical Trials/ISRCTN98785888
ISRCTN98785888
Completed
Not Applicable

A double-blind, randomised, placebo-controlled phase III study of the efficacy of a bivalent Pseudomonas aeruginosa flagella vaccine in patients with cystic fibrosis

The Society for the fight of Cystic Fibrosis (The Gesellschaft zur Bekämpfung der Mukoviszidose e.V.) (Germany)0 sites483 target enrollmentDecember 12, 2006
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ConditionsCystic fibrosisNutritional, Metabolic, Endocrine

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic fibrosis
Sponsor
The Society for the fight of Cystic Fibrosis (The Gesellschaft zur Bekämpfung der Mukoviszidose e.V.) (Germany)
Enrollment
483
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 12, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional

Investigators

Sponsor
The Society for the fight of Cystic Fibrosis (The Gesellschaft zur Bekämpfung der Mukoviszidose e.V.) (Germany)

Eligibility Criteria

Inclusion Criteria

  • •1\. Cystic fibrosis that has been diagnosed according to conventional criteria
  • •2\. Patients aged between two and 18 years
  • •3\. No infection with P. aeruginosa as assessed by a negative throat swab culture and negative serum antibody titres against the P. aeruginosa antigens exotoxin A
  • •4\. Alkaline protease and elastase in enzyme\-linked immunosorbent assays (ELISAs)
  • •5\. A forced expiratory volume in one second (FEV1\) of at least 70% of the predicted value
  • •6\. A weight\-to\-height ratio of at least 90%
  • •7\. An oxygen saturation of at least 92%

Exclusion Criteria

  • •1\. A known allergy to thiomersal or mercury
  • •2\. A prolonged bleeding time or a pathological partial thromboplastin time (PTT) value
  • •3\. Were using immunosuppressive drugs such as systemic corticosteroids
  • •4\. Participating in other clinical studies

Outcomes

Primary Outcomes

Not specified

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