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Aerosolized and Intravenous Colistin in Healthy Adults

NCT01863719 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-03-02

No results posted yet for this study

Summary

Colistin is amphipathic, cannot be absorbed from the gastrointestinal tract and is administered intramuscularly, intravenously (IV) or via inhalation. In the case of pneumonia, aerosolized route of administration is favorable as it presumably delivers a high concentration of drug directly to the infection site. Colistimethate sodium is an FDA approved drug, however, its aerosolized use represents a new method of administration not currently FDA-approved in the United States. In this proposal, the inactive prodrug colistimethate sodium has been selected to use for aerosolization as it is better tolerated than colistin sulphate. It is a randomized, open-labeled Phase 1 trial of aerosolized and/or IV formulations of colistin as multiple doses over seven days. The primary objective of this trial is to evaluate the safety and tolerability of multiple doses of aerosolized and intravenous colistimethate sodium separately or in combination in healthy adult subjects.

Conditions

  • Pathogen Resistance
  • Pneumococcal Infection
  • Pneumonia

Interventions

DRUG

Colistimethate sodium

Aerosol: In Dosing period 2 subjects receive 75mg colistin base activity via aerosol every 6 hours x 4 doses, followed by a washout period of at least 3 days. In Dosing period 3 subjects receive 75mg colistin base activity via aerosol every 6 hours x 4 doses in combination with 3.3mg/kg colistin base activity IV every 8 hours x 3 doses.

DRUG

Colistimethate sodium

Intravenous: In Dosing period 1 subjects receive 3.3mg/kg colistin base activity every 8 hours x 3 doses (total exposure 10mg/kg) intravenously (IV) followed by a washout period of at least 3 days. In Dosing period 3 subjects receive 3.3mg/kg colistin base activity IV every 8 hours x 3 doses in combination with 75mg colistin base activity via aerosol every 6 hours x 4 doses.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-06
Primary Completion
2017-05-04
Completion
2017-05-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01863719 on ClinicalTrials.gov