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primary studies published RCT

Eradication of early P. aeruginosa infection in children <7years of age with cystic fibrosis: The early study.

  • Year: 2018
  • Date: 2018
  • Author: Ratjen F
Source

J Cyst Fibros. 2018 Apr 20. pii: S1569-1993(18)30087-0. doi: 10.1016/j.jcf.2018.04.002.

Study design (if review, criteria of inclusion for studies)

Double-blind, randomised , placebo-controlled trial

Participants

CF patients <7years (N=51) with early Pa-infection

Interventions

Tobramycin inhalation solution (TOBI 300mg) or placebo (twice daily) for 28 days with an optional cross-over on Day 35.

Outcome measures

Primary endpoint was proportion of patients having throat swabs/sputum free of Pa on Day 29.

Main results

On Day 29, 84.6% patients in the TOBI versus 24.0% in the placebo group were Pa-free (p<0.001). At the end of the cross-over period, 76.0% patients receiving TOBI in the initial 28days were Pa-free compared to 47.8% receiving placebo initially. Adverse events were consistent with the TOBI safety profile with no differences between TOBI and placebo.

Authors' conclusions

TOBI was effective in eradicating early Pa-infection with a favourable safety profile in young CF patients.

Related topics

Antibiotic treatment of early pseudomonas aeruginosa

Antibiotics for pulmonary exacerbations

Inhaled antibiotics in cystic fibrosis

MRSA eradication in CF

Prophylactic use of oral antistaphylococcal antibiotic

Scheduled antibiotics every 3-4 months / symptom-based treatment

Keywords: Anti-Bacterial Agents; Bacterial Infections; Infection; Inhalation OR nebulised; pharmacological_intervention; Pseudomonas aeruginosa; Pseudomonas; Respiratory Tract Diseases; Respiratory Tract Infections; Tobramycin; non pharmacological intervention - devices OR physiotherapy; Aminoglycosides;