Cystic FibrosisNCT02489955
Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis
A study testing Amikacin, Tobramycin and Colomycin in people with Cystic Fibrosis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Adult patients with cystic fibrosis (CF) are treated with high dose antibiotics to reduce the long term damage to their lungs from infection. This would typically be with a two week course of intravenous antibiotics each time they have a chest infection (typically three to four times a year). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Amikacin, Tobramycin and Colomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CF*
- Able to give written informed consent
- Pulmonary exacerbation requiring IV tobramycin, amikacin or colistin based on the decision of the treating physician
Who cannot join
- Known allergy or adverse reaction to proposed antibiotic (tobramycin, amikacin or colistin)
- Pregnancy (if found to be pregnant during the study the participant will be immediately withdrawn)
- Continuation of nebulised aminoglycoside or colistin during IV treatment
- Use or intended use of NSAIDS
Trial locations and contacts
1 site in 1 country.
Giles Fitch contact
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
Giles Fitch, giles.fitch@nhs.net
About this study
Official title: Prospective Randomised Trial of 'Area Under the Curve' (AUC) Dosing Strategy for Intravenous Tobramycin Versus Standard Trough Dosing for Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis (CF)
Adult patients with cystic fibrosis (CF) are treated with high dose antibiotics to reduce the long term damage to their lungs from infection. This would typically be with a two week course of intravenous antibiotics each time they have a chest infection (typically three to four times a year).
The most effective and commonly used antibiotic in most cases is tobramycin. If this cannot be used because of previous side effects, allergy or a resistant infection then colomycin or amikacin are usually used. Each of these antibiotics are known to be toxic to both the kidneys and ear. As patients are living longer (into their forties), the total amount of these antibiotics they are receiving over their lifetime is increasing. This is now leading to increased complications such as kidney damage and hearing loss. Because of this, the investigators need to look at methods to accurately quantify damage and reduce potential kidney and hearing damage.
The investigators intend to quantify kidney damage by measuring new protein markers within the urine and blood that signify kidney damage before more conventional and currently available methods are able to.In those patients treated with intravenous tobramycin the investigators will also look at an alternative method used to calculate the most appropriate dose of antibiotic for each participant. This dosing method is called 'area under the curve or AUC' dose monitoring. This method currently in clinical use in other countries is thought to more accurately reflect the most appropriate dose for each participant and thus reduce the chance of kidney and hearing problems. This 'AUC' method requires two rather than one dose level to be checked each time a dose calculation is made. Participants receiving tobramycin will be randomised to receive dosing by this method or the investigators' currently used method of 'trough' monitoring.
- Conditions
- Cystic Fibrosis
- Being tested
- Amikacin, Tobramycin, Colomycin
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmikacinDrug
TobramycinDrug
ColomycinDrug
| Study group | Role | What they receive |
|---|---|---|
| AUC group | Experimental | Not described Receives: Drug: Amikacin; Drug: Colomycin |
| Trough dose monitoring | Active comparator | Not described Receives: Drug: Tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve' (AUC) of tobramycin
Measured: Days 1, 8, 14, 28
Area Under the Curve' (AUC) of Amikacin or Colomycin
Measured: Days 1, 8, 14, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489955
- Sponsor's protocol ID
- RM14/11283
- Status last verified
- Jul 2015
- First submitted
- 18 May 2015
- Last updated
- 3 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Trial of 'Area Under the Curve' (AUC) Dosing Strategy for Intravenous Tobramycin Versus Standard Trough Dosing for Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis (CF)
- ClinicalTrials.gov ID
- NCT02489955
- Acronym / sponsor ID
- RM14/11283
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adult patients with cystic fibrosis (CF) are treated with high dose antibiotics to reduce the long term damage to their lungs from infection. This would typically be with a two week course of intravenous antibiotics each time they have a chest infection (typically three to four times a year).
The most effective and commonly used antibiotic in most cases is tobramycin. If this cannot be used because of previous side effects, allergy or a resistant infection then colomycin or amikacin are usually used. Each of these antibiotics are known to be toxic to both the kidneys and ear. As patients are living longer (into their forties), the total amount of these antibiotics they are receiving over their lifetime is increasing. This is now leading to increased complications such as kidney damage and hearing loss. Because of this, the investigators need to look at methods to accurately quantify damage and reduce potential kidney and hearing damage.
The investigators intend to quantify kidney damage by measuring new protein markers within the urine and blood that signify kidney damage before more conventional and currently available methods are able to.In those patients treated with intravenous tobramycin the investigators will also look at an alternative method used to calculate the most appropriate dose of antibiotic for each participant. This dosing method is called 'area under the curve or AUC' dose monitoring. This method currently in clinical use in other countries is thought to more accurately reflect the most appropriate dose for each participant and thus reduce the chance of kidney and hearing problems. This 'AUC' method requires two rather than one dose level to be checked each time a dose calculation is made. Participants receiving tobramycin will be randomised to receive dosing by this method or the investigators' currently used method of 'trough' monitoring.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUC group | Experimental | Drug: Amikacin, Drug: Colomycin |
| Trough dose monitoring | Active comparator | Drug: Tobramycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of CF*
- Able to give written informed consent
- Pulmonary exacerbation requiring IV tobramycin, amikacin or colistin based on the decision of the treating physician
Key exclusion criteria (4 listed)
- Known allergy or adverse reaction to proposed antibiotic (tobramycin, amikacin or colistin)
- Pregnancy (if found to be pregnant during the study the participant will be immediately withdrawn)
- Continuation of nebulised aminoglycoside or colistin during IV treatment
- Use or intended use of NSAIDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amikacin | Drug | AUC group |
| Tobramycin | Drug | Trough dose monitoring |
| Colomycin | Drug | AUC group |
Primary outcome
Area Under the Curve' (AUC) of tobramycin
Time frame: Days 1, 8, 14, 28
Area Under the Curve' (AUC) of Amikacin or Colomycin
Time frame: Days 1, 8, 14, 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giles Fitch contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amikacin, Tobramycin and Colomycin in people with Cystic Fibrosis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giles Fitch (giles.fitch@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve' (AUC) of tobramycin (time frame: Days 1, 8, 14, 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015.