Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria

PHASE3TerminatedINTERVENTIONAL
Enrollment

149

Participants

Timeline

Start Date

November 28, 2017

Primary Completion Date

May 27, 2020

Study Completion Date

September 23, 2021

Conditions
Pseudomonas Aeruginosa Respiratory Tract Infection/ColonizationCystic Fibrosis
Interventions
DRUG

AZLI

Administered via the PARI Altera® Nebulizer System. Participants \< 2 years will receive via the SmartMask® Baby, 2 to \< 6 years via the SmartMask Kids® and \> 6 years via the nebulizer mouthpiece.

DRUG

Placebo

Administered via the PARI Altera® Nebulizer System. Participants \< 2 years will receive via the SmartMask® Baby, 2 to \< 6 years via the SmartMask Kids® and \> 6 years via the nebulizer mouthpiece.

Trial Locations (53)

1020

Hopital Universitaire des Enfants Reine Fabiola, Brussels

2100

Rigshospitalet, Copenhagen

2650

UZ Antwerpen, Edegem

8036

Medizinische Universitat Graz, Graz

8200

Aarhus University Hospital, Aarhus N

20010

Children's National Health System, Washington D.C.

20122

Fondazione IRCCS ca Granda, Milan

24116

Stadtisches Krankenhaus Kiel, Kiel

28046

Hospital Universitario La Paz, Madrid

28277

Clinical Research of Charlotte, Charlotte

29011

Hospital Regional Universitario de Malaga, Málaga

29203

USC Department of Pediatrics/Division of Pediatric Pulmonology, Columbia

33076

Hopital des enfants - GH Pellegrin, Bordeaux

33701

Johns Hopkins All Children's Hospital Outpatient Care Center, St. Petersburg

37126

Azienda Ospedaliera Universitaria Integrata Verona, Verona

38043

CHU Grenoble Alpes, Grenoble

39216

University of Mississippi Medical center, Jackson

41013

Hospital Universitario Virgen del Rocio, Seville

44195

Cleveland Clinic, Cleveland

45147

Universitatsklinikum Essen, Essen

46010

Hospital Clinico Universitario, Valencia

54642

General Hospital of Thessaloniki,3rd Dept of Pediatrics, Thessaloniki

60611

Ann & Robert H Lurie Childrens Hospital of Chicago, Chicago

60637

Corner Children's Hospital, Chicago

75019

Hopital Robert Debre APHP, Paris

75708

The University of Texas Health Science Center at Tyler, Tyler

76104

Cook Children's Medical Center, Fort Worth

80131

"Azienda Ospedaliera Universitaria Federico II", Napoli

84132

University of Utah, Salt Lake City

94158

University of California San Francisco (UCSF) - Benioff Children's Hospital, San Francisco

95123

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania

3109601

Rambam Health Corporation, Haifa

3436212

Lady Davis Carmel Medical Center, Haifa

4920230

Schneider Children's Medical Center of Israel, Petah Tikva

9765422

Hadassah University Hospital Mount Scopus, Jerusalem

06020

Medizinische Universitat Innsbruck, Innsbruck

00161

Azienda Policlinico Umberto - Universita La Sapienza di Roma, Roma

00165

Ospedale Pediatrico Bambino Gesu, Roma

1081 HV

VU University Medical Center, Amsterdam

08035

Hospital Universitario Vall d Hebron, Barcelona

08950

Hospital Sant Joan de Deu, Esplugues de Llobregat

08208

Corporacio Sanitaria Parc Tauli, Sabadell

AB25 2ZG

NHS Grampian, Aberdeen

B4 6NH

Birmingham Children's Hospital NHS Foundation Trust, Birmingham

EX2 5DW

Royal Devon and Exeter Foundation NHS Trust, Exeter

LE1 5WW

University Hospitals of Leicester NHS trust, Leicester

E1 1BB

Barts and the London Children's Hospital, London

SE5 9RS

Kings College Hospital NHS foundation Trust, London

M13 9WL

Royal Manchester Children's Hospital, Manchester

TS4 3BW

South Tees Hospitals NHS Foundation Trust, Middlesbrough

S10 2TH

Sheffield Children's Hospital NHS Trust, Sheffield

SO16 6YD

Southampton University Hospitals NHS trust, Southampton General Hospital, Southampton

ST4 6QG

University Hospitals of North Midlands NHS trust Royal Stoke University Hospital, Stoke-on-Trent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT03219164 - Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria | Biotech Hunter | Biotech Hunter