Cystic FibrosisNCT02048163
Intermittent Versus Continuous Infusion Meropenem in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Dayton Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to compare the incidence of nausea and vomiting following short intermittent versus prolonged intermittent infusion of meropenem. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Cystic Fibrosis
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Aug 2015
- Phase
- Observational
- 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 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male and female patients with cystic fibrosis ages 7 to 21 who are admitted to Dayton Children's Hospital and who will receive meropenem as part of their treatment regimen.
Who may be able to join
- Be an admitted patient at Dayton Children's Hospital.
- Between 7 and 21 years of age.
- Have a documented CF diagnosis with one or more of the following clinical features:
- Sweat chloride > 60 mEq/liter as determined by quantitative pilocarpine iontophoresis test (QPIT).
- Two mutations (well characterized) in the cystic fibrosis transmembrane conductive regulator (CTFR) gene.
- Abnormal nasal potential difference.
Show all 24Show fewer
- Based on Hankinson/NHanes III criteria, are able to elicit an FEV1 > 25% but with < 95% predicted value when admitted.
- Sputum or throat swab specimen positive for P. aeruginosa and have a history of at least one additional sputum culture positive for P. aeruginosa within the last 12 months.
- Are able to perform an acceptable spirometry session (defined as 3 acceptable or usable efforts per ATS/ERS criteria upon admission).
- Have not smoked tobacco within 28 days prior to Visit 1 and agree not to smoke for the duration of the study.
- Are able to and have given written informed consent (if they are adults) or assent in combination with consent of their legal representative(s) (if they are minors) in a manner approved by the Institutional Review Board.
- Patient is experiencing symptoms of CF exacerbation of CF: with any 4 of the following 12 signs or symptoms:
- Change in sputum;
- New or increased hemoptysis;
- Increased cough;
- Increased dyspnea;
- Malaise, fatigue or lethargy;
- Temperature above 38°C;
- Anorexia or weight loss;
- Sinus pain or tenderness;
- Change in sinus discharge;
- Change in physical examination of the chest;
- Decrease in pulmonary function by 10 percent or more from a previously recorded value;
- Radiographic changes indicative of pulmonary infection.
Who cannot join
- History of hypersensitivity or intolerance to meropenem.
- History of hypersensitivity or intolerance to granisetron.
- Are pregnant, breastfeeding, or unwilling to practice a highly effective method of birth control or abstinence during participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Effect of Intermittent and Continuous Infusion of Meropenem on the Prevalence of Nausea in Pediatric Cystic Fibrosis Patients
The purpose of this study is to compare the incidence of nausea and vomiting following short intermittent versus prolonged intermittent infusion of meropenem.
Read the detailed description
- To assess the number of episodes of emesis following both short and prolonged intermittent infusion of meropenem.
- To assess the number of episodes of emesis corresponding to the peak serum concentration of meropenem.
- To assess the number of episodes of emesis corresponding to the area under the meropenem serum concentration time curve.
- To assess reported nausea, measured through administered dosages of anti-nausea medication, following both short and prolonged intermittent infusion of meropenem.
- To assess reported nausea, measured through administered doses of anti-nausea medication, corresponding to peak concentrations of meropenem.
- To assess reported nausea, measured through administered dosages of anti-nausea medication, corresponding to the area under the serum concentration time curve
- To assess reported nausea, measured through patient-reported nausea measured using pictorial scales of severity of nausea in pediatric patients, following both short and prolonged intermittent infusion of meropenem.
- To assess reported nausea, measured through patient-reported nausea measured using pictorial scales of severity corresponding to the peak serum concentrations of meropenem.
- To assess reported nausea, measured through patient-reported nausea measured using pictorial scales of severity corresponding to the area under the meropenem serum concentration time curve.
- Conditions
- Cystic Fibrosis
- Keywords
- Meropenem, Nausea, Pharmacokinetics
- Medical subject headings
- Cystic Fibrosis, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Short infusion meropenem | Meropenem 20 mg/ml IV will be administered at a dose of 40 mg/kg (maximum 2,000 mg) every eight hours for 12 doses and will be infused over a 30 minute period. An equal volume of normal saline will be infused at the same time over four hours. | |
| Prolonged infusion meropenem | Meropenem 20 mg/ml IV will be administered at a dose of 40 mg/kg (maximum 2,000 mg) every eight hours for 12 doses and will be infused over a four hour period. An equal volume of normal saline will be infused at the same time over 30 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare indices of nausea following both prolonged intermittent and short intermittent infusions of meropenem
Nausea indices will be measured for each treatment arm by averaging the doses of granisetron requested by each patient, the number of episodes of emesis, and the nausea faces scale scores recorded by patients.
Measured: Nausea will be assessed while patient is receiving 4 days of prolonged intermittent infusion and 4 days of short intermittent infusion.
Secondary outcomes (1)
Compare pharmacokinetic data to indices of nausea.
Blood samples will be obtained at 0.5, 1.0 and 1.5 hours after the third, fourth or fifth meropenem dose on each arm of the study. Area under the serum concentration time curve and peak serum concentrations will be compared to each of the nausea indices.
Measured: Pharmacokinetic data will be obtained following the third, fourth, or fifth dose of meropenem administered during of each arm of the study. Peak serum concentration and area under the serum concentration time curve will be compared to nausea indices.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: No subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dayton Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pat Christoff, PharmD, Principal investigator, Dayton Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048163
- Sponsor's protocol ID
- DCH 2013-034
- Status last verified
- Jan 2015
- First submitted
- 27 Jan 2014
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Prescott WA Jr, Gentile AE, Nagel JL, Pettit RS. Continuous-infusion antipseudomonal Beta-lactam therapy in patients with cystic fibrosis. P T. 2011 Nov;36(11):723-63.
PubMed 22346306Norrby SR, Gildon KM. Safety profile of meropenem: a review of nearly 5,000 patients treated with meropenem. Scand J Infect Dis. 1999;31(1):3-10. doi: 10.1080/00365549950161808.
PubMed 10381210Lodise TP, Lomaestro BM, Drusano GL; Society of Infectious Diseases Pharmacists. Application of antimicrobial pharmacodynamic concepts into clinical practice: focus on beta-lactam antibiotics: insights from the Society of Infectious Diseases Pharmacists. Pharmacotherapy. 2006 Sep;26(9):1320-32. doi: 10.1592/phco.26.9.1320.
PubMed 16945055Du X, Li C, Kuti JL, Nightingale CH, Nicolau DP. Population pharmacokinetics and pharmacodynamics of meropenem in pediatric patients. J Clin Pharmacol. 2006 Jan;46(1):69-75. doi: 10.1177/0091270005283283.
PubMed 16397286Legrand T, Chhun S, Rey E, Blanchet B, Zahar JR, Lanternier F, Pons G, Jullien V. Simultaneous determination of three carbapenem antibiotics in plasma by HPLC with ultraviolet detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Nov 15;875(2):551-6. doi: 10.1016/j.jchromb.2008.09.020. Epub 2008 Sep 25.
PubMed 18848512Blumer JL, Reed MD, Kearns GL, Jacobs RF, Gooch WM 3rd, Yogev R, Willims K, Ewing BJ. Sequential, single-dose pharmacokinetic evaluation of meropenem in hospitalized infants and children. Antimicrob Agents Chemother. 1995 Aug;39(8):1721-5. doi: 10.1128/AAC.39.8.1721.
PubMed 7486908
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effect of Intermittent and Continuous Infusion of Meropenem on the Prevalence of Nausea in Pediatric Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT02048163
- Acronym / sponsor ID
- DCH 2013-034
- Conditions
- Cystic Fibrosis
- Keywords
- Meropenem, Nausea, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dayton Children's HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Jan 2014 (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.
The purpose of this study is to compare the incidence of nausea and vomiting following short intermittent versus prolonged intermittent infusion of meropenem.
Detailed description
- To assess the number of episodes of emesis following both short and prolonged intermittent infusion of meropenem.
- To assess the number of episodes of emesis corresponding to the peak serum concentration of meropenem.
- To assess the number of episodes of emesis corresponding to the area under the meropenem serum concentration time curve.
- To assess reported nausea, measured through administered dosages of anti-nausea medication, following both short and prolonged intermittent infusion of meropenem.
- To assess reported nausea, measured through administered doses of anti-nausea medication, corresponding to peak concentrations of meropenem.
- To assess reported nausea, measured through administered dosages of anti-nausea medication, corresponding to the area under the serum concentration time curve
- To assess reported nausea, measured through patient-reported nausea measured using pictorial scales of severity of nausea in pediatric patients, following both short and prolonged intermittent infusion of meropenem.
- To assess reported nausea, measured through patient-reported nausea measured using pictorial scales of severity corresponding to the peak serum concentrations of meropenem.
- To assess reported nausea, measured through patient-reported nausea measured using pictorial scales of severity corresponding to the area under the meropenem serum concentration time curve.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short infusion meropenem | – | –Meropenem 20 mg/ml IV will be administered at a dose of 40 mg/kg (maximum 2,000 mg) every eight hours for 12 doses and will be infused over a 30 minute period. An equal volume of normal saline will be infused at the same time over four hours. |
| Prolonged infusion meropenem | – | –Meropenem 20 mg/ml IV will be administered at a dose of 40 mg/kg (maximum 2,000 mg) every eight hours for 12 doses and will be infused over a four hour period. An equal volume of normal saline will be infused at the same time over 30 minutes. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male and female patients with cystic fibrosis ages 7 to 21 who are admitted to Dayton Children's Hospital and who will receive meropenem as part of their treatment regimen.
Key inclusion criteria (24 listed)
- Be an admitted patient at Dayton Children's Hospital.
- Between 7 and 21 years of age.
- Have a documented CF diagnosis with one or more of the following clinical features:
- Based on Hankinson/NHanes III criteria, are able to elicit an FEV1 > 25% but with < 95% predicted value when admitted.
- Sputum or throat swab specimen positive for P. aeruginosa and have a history of at least one additional sputum culture positive for P. aeruginosa within the last 12 months.
Key exclusion criteria (3 listed)
- History of hypersensitivity or intolerance to meropenem.
- History of hypersensitivity or intolerance to granisetron.
- Are pregnant, breastfeeding, or unwilling to practice a highly effective method of birth control or abstinence during participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare indices of nausea following both prolonged intermittent and short intermittent infusions of meropenem
Time frame: Nausea will be assessed while patient is receiving 4 days of prolonged intermittent infusion and 4 days of short intermittent infusion.
Nausea indices will be measured for each treatment arm by averaging the doses of granisetron requested by each patient, the number of episodes of emesis, and the nausea faces scale scores recorded by patients.
1 secondary outcome
Compare pharmacokinetic data to indices of nausea.
Time frame: Pharmacokinetic data will be obtained following the third, fourth, or fifth dose of meropenem administered during of each arm of the study. Peak serum concentration and area under the serum concentration time curve will be compared to nausea indices.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Background: PubMed 22346306Prescott WA Jr, Gentile AE, Nagel JL, Pettit RS. Continuous-infusion antipseudomonal Beta-lactam therapy in patients with cystic fibrosis. P T. 2011 Nov;36(11):723-63.
- Background: PubMed 10381210Norrby SR, Gildon KM. Safety profile of meropenem: a review of nearly 5,000 patients treated with meropenem. Scand J Infect Dis. 1999;31(1):3-10. doi: 10.1080/00365549950161808.
- Background: PubMed 16945055Lodise TP, Lomaestro BM, Drusano GL; Society of Infectious Diseases Pharmacists. Application of antimicrobial pharmacodynamic concepts into clinical practice: focus on beta-lactam antibiotics: insights from the Society of Infectious Diseases Pharmacists. Pharmacotherapy. 2006 Sep;26(9):1320-32. doi: 10.1592/phco.26.9.1320.
- Background: PubMed 16397286Du X, Li C, Kuti JL, Nightingale CH, Nicolau DP. Population pharmacokinetics and pharmacodynamics of meropenem in pediatric patients. J Clin Pharmacol. 2006 Jan;46(1):69-75. doi: 10.1177/0091270005283283.
- Background: PubMed 18848512Legrand T, Chhun S, Rey E, Blanchet B, Zahar JR, Lanternier F, Pons G, Jullien V. Simultaneous determination of three carbapenem antibiotics in plasma by HPLC with ultraviolet detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Nov 15;875(2):551-6. doi: 10.1016/j.jchromb.2008.09.020. Epub 2008 Sep 25.
- Background: PubMed 7486908Blumer JL, Reed MD, Kearns GL, Jacobs RF, Gooch WM 3rd, Yogev R, Willims K, Ewing BJ. Sequential, single-dose pharmacokinetic evaluation of meropenem in hospitalized infants and children. Antimicrob Agents Chemother. 1995 Aug;39(8):1721-5. doi: 10.1128/AAC.39.8.1721.
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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.
Pat Christoff, PharmD principal investigator
Dayton Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Dayton Children's Hospital at 1 site in United States.
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 24 inclusion and 3 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: withdrawn, as of the sponsor's last update on 8 Feb 2016. 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 States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare indices of nausea following both prolonged intermittent and short intermittent infusions of meropenem (time frame: Nausea will be assessed while patient is receiving 4 days of prolonged intermittent infusion and 4 days of short intermittent infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02048163, which also lists 6 linked publications.
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 8 Feb 2016.