Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis

NCT03066453 | Terminated Phase 3 DMC

• 3 other identifiers: 2014_212014-003882-10PHRC I 2013
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 7

Brief Summary

The aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the case of positive results, the reduction of the duration of IV treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis, tobramycin, antibiotic courses, FEV1

Outcome Measures

Primary Outcomes (1)

• Forced expiratory volume at one second (FEV1) by spirometry

  measure of dyspnea

  18 months of the cure

Secondary Outcomes (6)

• Forced expiratory volume at one second (FEV1) by spirometry

  baseline and between day 16 or day 22

• Visual Analog Scale

  baseline and between day 16 or day 22

• number of participants with Bronchial congestion

  baseline and between day 16 or day 22

• Sputum sample culture

  baseline and between day 16 or day 22

• Occurrence of the first exacerbation after the cure

  during 18 months

Study Arms (2)

Standard cure

EXPERIMENTAL

Antibiotic IV (Nebcin) 14 days and 14 days of tobramycin IV associated with one or more other antibiotic (s) IV in routine care

Drug: Tobi Inhalant Product; Drug: Nebcin

Short cure

EXPERIMENTAL

antibiotic IV (Nebcin)14 days but with only 5 days of tobramycin IV followed 9 days of inhaled tobramycin (Tobi Inhalant Product) associated with one or more other antibiotic (s) IV in routine care

Drug: Tobi Inhalant Product; Drug: Nebcin

Interventions

Tobi Inhalant Product DRUG

inhaled tobramycin 300 mg twice per day

Short cure; Standard cure

Nebcin DRUG

10 to 12 mg/kg/day in 1 injection for adults and 10 to 15 mg/kg in 1 pediatric injection (combined with another IV antibiotic)

Short cure; Standard cure

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with cystic fibrosis confirmed by sweat or genetic test
• Patient with clinical signs of exacerbation (increased cough, sputum (abundance, purulence), fever, anorexia, weight loss and FEV1) or acute exacerbations (defined at the clinician's discretion )
• FEV1 ≥ 25%
• Pseudomonas aeruginosa chronic carriers (defined by at least two antipyocyanic precipitation arcs or at least 3 successive positive ECBCs over a period of 18 months)

You may not qualify if:

• Severe exacerbation (requiring hospitalization due to severe amputation of FEV 1, oxygen deficiency, or severe impairment of general health).
• Patient with 3rd antibiotic therapy (triple therapy)
• Patient colonized in Burkholderia cepacia
• Patient colonized by an atypical mycobacterium
• Patient with pulmonary transplant or transplant
• chronic tinnitus
• patient using hearing aid
• Hypersensitivity to tobramycin and other antibiotics of the aminoglycoside family
• Cirrhosis of Grades B and C according to the Child-Pugh Classification
• Myasthenia gravis
• Simultaneous administration of another aminoglycoside
• Renal failure
• Patient participating simultaneously in another clinical study conducted on a drug for the duration of its participation in this research

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (7)

CRCM pédiatrique - CHU d'Amiens Hôpital Nord

Amiens, France

Location

CRCM mixte - CHU de Caen Hôpital Côte de Nacre

Caen, France

Location

CRCM mixte - CH de Dunkerque

Dunkirk, France

Location

CRCM mixte - CH de Lens

Lens, France

Location

CRCM adulte - CHRU de Lille Hôpital Calmette

Lille, France

Location

CRCM pédiatrique - CHRU de Lille Hôpital Jeanne de Flandres

Lille, France

Location

CRCM mixte - CHU de Rouen Hôpital Charles Nicolle

Rouen, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Anne Prévotat, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: June 13, 2017
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)