Intermittent Versus Continuous Infusion Meropenem in Cystic Fibrosis
Information source: Dayton Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Phase: Phase 4
Status: Recruiting
Sponsored by: Dayton Children's Hospital Official(s) and/or principal investigator(s): Pat Christoff, PharmD, Principal Investigator, Affiliation: Dayton Children's Hospital
Summary
The purpose of this study is to compare the incidence of nausea and vomiting following short
intermittent versus prolonged intermittent infusion of meropenem.
Clinical Details
Official title: A Comparison of the Effect of Intermittent and Continuous Infusion of Meropenem on the Prevalence of Nausea in Pediatric Cystic Fibrosis Patients
Study design: Observational Model: Case-Crossover, Time Perspective: Prospective
Primary outcome: Compare indices of nausea following both prolonged intermittent and short intermittent infusions of meropenem
Secondary outcome: Compare pharmacokinetic data to indices of nausea.
Detailed description:
1. To assess the number of episodes of emesis following both short and prolonged
intermittent infusion of meropenem.
2. To assess the number of episodes of emesis corresponding to the peak serum
concentration of meropenem.
3. To assess the number of episodes of emesis corresponding to the area under the
meropenem serum concentration time curve.
4. To assess reported nausea, measured through administered dosages of anti-nausea
medication, following both short and prolonged intermittent infusion of meropenem.
5. To assess reported nausea, measured through administered doses of anti-nausea
medication, corresponding to peak concentrations of meropenem.
6. To assess reported nausea, measured through administered dosages of anti-nausea
medication, corresponding to the area under the serum concentration time curve
7. 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.
8. To assess reported nausea, measured through patient-reported nausea measured using
pictorial scales of severity corresponding to the peak serum concentrations of
meropenem.
9. 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.
Eligibility
Minimum age: 7 Years.
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Be an admitted patient at Dayton Children's Hospital.
2. Between 7 and 21 years of age.
3. Have a documented CF diagnosis with one or more of the following clinical features:
1. Sweat chloride > 60 mEq/liter as determined by quantitative pilocarpine
iontophoresis test (QPIT).
2. Two mutations (well characterized) in the cystic fibrosis transmembrane
conductive regulator (CTFR) gene.
3. Abnormal nasal potential difference.
4. Based on Hankinson/NHanes III criteria, are able to elicit an FEV1 > 25% but with <
95% predicted value when admitted.
5. 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.
6. Are able to perform an acceptable spirometry session (defined as 3 acceptable or
usable efforts per ATS/ERS criteria upon admission).
7. Have not smoked tobacco within 28 days prior to Visit 1 and agree not to smoke for
the duration of the study.
8. 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.
9. 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.
Exclusion Criteria:
1. History of hypersensitivity or intolerance to meropenem.
2. History of hypersensitivity or intolerance to granisetron.
3. Are pregnant, breastfeeding, or unwilling to practice a highly effective method of
birth control or abstinence during participation in the study.
Locations and Contacts
Dayton Children's Hospital, Dayton, Ohio 45404, United States; Recruiting Patricia B Christoff, Pharm D, Phone: 937-641-3031, Email: christoffp@childrensdayton.org Robert J Fink, MD, Phone: 937 641-4029, Email: finkr@childrensdayton.org Patricia B Christoff, Pharm D, Principal Investigator Marissa Cushing, Pharm D cand, Sub-Investigator Juanita Draime, Pharm D cand, Sub-Investigator Bao-Ngoc Ho, Pharm D cand, Sub-Investigator Jordan Nicholls, Pharm D cand, Sub-Investigator Bethany Sibbitt, Pharm D cand, Sub-Investigator Rebecca Widder, Pharm D cand, Sub-Investigator Denise Simpson, PhD, Sub-Investigator Rebecca Gryka, PhD, Sub-Investigator
Additional Information
Related 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. Norrby 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. Review. Lodise 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. Review. Du 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. Legrand 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. Blumer 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.
Starting date: December 2013
Last updated: February 23, 2015
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