LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients

NCT02840136 | Terminated

• 2 other identifiers: EC UZG 2015/1504B670201526932
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this trial, various factors that may influence the antibiotic concentrations measured in the sputum of cystic fibrosis patients are studied. A first factor is aerosol use. As cystic fibrosis patients often use aerosols, such as hypertonic saline, dilution of the antibiotics in sputum can be expected. The extent of this dilution is unknown and will be determined by comparing sputum samples collected before and after the use of an aerosol. A second factor is the homogeneity of the antibiotics within one sputum sample. Multiple aliquots of the same sputum sample will be compared. A third factor is the variability between several sputum samples collected during a drainage session. The antibiotic concentrations in 3 separate sputum samples will be compared. The final goal is to standardise the sputum sample collection and processing of the samples to ensure a accurate concentration measurements in sputum.

Conditions

Cystic Fibrosis

Keywords

Respiratory infection; Antibiotic therapy; LC-MS/MS; Sputum antibiotic concentrations

Outcome Measures

Primary Outcomes (3)

• Concentration changes induced by aerosol use

  The antibiotic concentration changes in sputum induced by aerosol use are monitored over a period of 2 hours

  2 h

• Antibiotic distribution in single sputum sample

  In a single sputum sample, the homogeneity of the antibiotic distribution is evaluated

  0 h

• Antibiotic concentration in subsequently collected samples from the same patient

  Antibiotic concentrations are measured in sputum samples collected at the beginning, middle and end of a 30 minute autogenic drainage session

  30 min

Study Arms (1)

Standard of care

EXPERIMENTAL

Sputum is collected from patients receiving standard of care therapy with IV piperacillin-tazobactam, ceftazidime or meropenem

Drug: Piperacillin-tazobactam combination product; Drug: Meropenem; Drug: Ceftazidime

Interventions

Piperacillin-tazobactam combination product DRUG

Standard of care

Meropenem DRUG

Standard of care

Ceftazidime DRUG

Standard of care

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cystic fibrosis patient
• Sputum production

You may not qualify if:

• \- Inability to expectorate sputum

Sponsors & Collaborators

• University Ghent: lead
• King Baudouin Foundation: collaborator
• Belgische Vereniging voor Strijd tegen Mucoviscidose: collaborator

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis; Respiratory Tract Infections

Interventions

Piperacillin, Tazobactam Drug Combination; Meropenem; Ceftazidime

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; Infections

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Thienamycins; Carbapenems; Cephaloridine; Cephalosporins; Thiazines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 21, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)