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

NCT02840136 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-12-15

No results posted yet for this study

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

Interventions

DRUG

Piperacillin-tazobactam combination product

DRUG

Meropenem

DRUG

Ceftazidime

Sponsors & Collaborators

  • King Baudouin Foundation

    collaborator OTHER

  • Belgische Vereniging voor Strijd tegen Mucoviscidose

    collaborator UNKNOWN

  • University Ghent

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-09-01
Completion
2017-09-01

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02840136 on ClinicalTrials.gov