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HTA - Health Technology Assessment Report

Discontinuation versus continuation of hypertonic saline or dornase alfa in modulator treated people with cystic fibrosis (SIMPLIFY): results from two parallel, multicentre, open-label, randomised, controlled, non-inferiority trials.

  • Year: 2023
  • Date: 2013
  • Author: Mayer-Hamblett N
Source

Lancet Respir Med. 2023 Apr;11(4):329-340. doi: 10.1016/S2213-2600(22)00434-9. Epub 2022 Nov 4.

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

A limited literature search of key resources was conducted, and titles and abstracts of the retrieved publications were reviewed. Full-text publications were evaluated for final article selection according to predetermined selection criteria (population, intervention, comparator, outcomes, and study designs).

Participants

patients with CF and Pseudomonas aeruginosa

Interventions

Tobramycin (inhaled vs IV tobramycin)

Outcome measures

clinical effectiveness, cost effectiveness

Main results

The literature search produced 527 citations, with an additional 3 studies identified from other sources. Of these, 41 were deemed potentially relevant and 5 met the criteria for inclusion in this review — 3 retrospective studies and 2 evidence-based guidelines. For the treatment of patients with CF there was no evidence found comparing inhaled and IV tobramycin. No decline in kidney function was found with long-term inhaled or IV tobramycin therapy. Adherence rates were low with inhaled tobramycin (increasing hospitalization risk). No evidence was identified for adherence with IV tobramycin therapy.

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; Child; Infant; Infection; Inhalation OR nebulised; Intravenous; pharmacological_intervention; Pneumonia; Pseudomonas aeruginosa; Pseudomonas; Respiratory Tract Diseases; Respiratory Tract Infections; Tobramycin; Aminoglycosides;