Intermittent Versus Continuous Infusion Meropenem in Cystic Fibrosis

February 4, 2016 updated by: Dayton Children's Hospital

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.

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Dayton, Ohio, United States, 45404
        • Dayton Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Nausea will be assessed while patient is receiving 4 days of prolonged intermittent infusion and 4 days of short intermittent infusion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dayton Children's Hospital

Investigators

  • Principal Investigator: Pat Christoff, PharmD, Dayton Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCH 2013-034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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