Intermittent Versus Continuous Infusion Meropenem in Cystic Fibrosis

NCT02048163 | Withdrawn

• 1 other identifier: DCH 2013-034
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the incidence of nausea and vomiting following short intermittent versus prolonged intermittent infusion of meropenem.

Conditions

Cystic Fibrosis

Keywords

Meropenem; Nausea; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dayton Children's Hospital: lead

Study Sites (1)

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

Related Publications (6)

• 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.

  PMID: 22346306 BACKGROUND

• 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. doi: 10.1080/00365549950161808.

  PMID: 10381210 BACKGROUND

• 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. doi: 10.1592/phco.26.9.1320.

  PMID: 16945055 BACKGROUND

• 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. doi: 10.1177/0091270005283283.

  PMID: 16397286 BACKGROUND

• 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.

  PMID: 18848512 BACKGROUND

• 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. doi: 10.1128/AAC.39.8.1721.

  PMID: 7486908 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Cystic Fibrosis; Nausea

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pat Christoff, PharmD

  Dayton Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 29, 2014
• Study Start: December 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 8, 2016

Record last verified: 2015-01

Locations

US (1)