Circadian Rhythm In Tobramycin Elimination In Cystic Fibr... | NCT01207245

Studies
Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis

NCT01207245

Sponsor

University of Nottingham

Status

Completed

Last Update Posted

Jun 23, 2015Estimated

Enrollment

18Actual

Phase

Phase 4

Conditions

Cystic Fibrosis

Interventions

Tobramycin time of administration

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NIHR RfPB PB-PG-1207-15025	Other Grant/Funding Number	National Institute of Health Research

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

May 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Sep 21, 2010

First Submission Date that Met QC Criteria

Sep 21, 2010

First Posted Date

Sep 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2015

Last Update Posted Date

Jun 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cystic fibrosis is the most common inherited life limiting condition which affects children. Patients with it develop lung infections which become difficult to clear, and damage the lungs. These are treated with antibiotics (such as tobramycin) into the vein (termed "intravenous antibiotics"). This has without doubt improved survival. However, all treatments have side effects. Tobramycin can cause kidney damage. The investigators have preliminary data that suggests that administering tobramycin in the morning may be safer for the kidneys than administering it in the evening.

The investigators plan to approach children and adults with cystic fibrosis whose doctors have decided to administer a course of intravenous tobramycin. The investigators will randomly allocate them to receive it at either 0800h or 2200h. The investigators will measure the rate at which the body eliminates tobramycin from the bloodstream, by measuring the amount of tobramycin in the blood stream after administering the antibiotic. For each patient the study will last for the duration of the course of antibiotics. This is decided by the doctor looking after the patient (rather than the researcher), and would typically be 14 days. The investigators will also measure substances in the blood and urine ("biomarkers") which are sensitive indicators of low levels of kidney injury. The investigators will monitor lung function and lung bacteria in both the groups to ensure that the patients in both groups improve by the same amount.

If the preliminary data are proved correct, this research will allow investigators to improve the safety profile of tobramycin, one of the most widely prescribed drugs in cystic fibrosis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Morning dose of tobramycin	Active Comparator	Administration of tobramycin once daily dose in the morning	Other: Tobramycin time of administration
Evening tobramycin	Active Comparator	Evening dose of tobramycin once daily	Other: Tobramycin time of administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tobramycin time of administration	Other	Random allocation to time of day of administration of tobramycin	Evening tobramycin Morning dose of tobramycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal Elimination Rate Constant of Tobramycin		Days 1, 8 and 14

Secondary Outcomes

Measure	Description	Time Frame
Weight		Day 1, 8, 14
Pulmonary Function		Day 1, 8, 14
Urinary Biomarkers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of cystic fibrosis (CF) (defined as clinical features of CF plus a positive sweat test OR the presence of 2 genes known to be associated with CF disease)
Males or female 5 years and older
Treating doctor has decided to commence a course of tobramycin
Patient or parent / legal guardian able to give informed consent

Exclusion Criteria:

Previous episode of acute kidney injury
Solid organ transplantation
Evidence of impaired renal function (raised serum creatinine above the normal range for age)
Once daily aminoglycoside unsuitable because of hypersensitivity or previous high trough levels on once daily dosing.
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan Smyth	University of Nottingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nottingham University Hospitals NHS Trust		Nottingham	Nottinghamshire	NG7 2UH	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26282839	Derived	Prayle AP, Jain K, Touw DJ, Koch BC, Knox AJ, Watson A, Smyth AR. The pharmacokinetics and toxicity of morning vs. evening tobramycin dosing for pulmonary exacerbations of cystic fibrosis: A randomised comparison. J Cyst Fibros. 2016 Jul;15(4):510-7. doi: 10.1016/j.jcf.2015.07.012. Epub 2015 Aug 15.

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases