Trial · NCT01222585

Metronidazole Pharmacokinetics (PK) in Premature Infants

NCT01222585, Phase 1, Completed, Michael Cohen-Wolkowiez; results first posted 2013-12-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Metronidazole Pharmacokinetics (PK) in Premature Infants. Trials, record NCT01222585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01222585

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Metronidazole Pharmacokinetics (PK) in Premature Infants
NCT number: NCT01222585
Status: Completed
Phases: Phase 1
Enrollment: 24 participants, actual
Lead sponsor: Michael Cohen-Wolkowiez
Conditions: Serious Systemic Infections, Necrotizing Enterocolitis
Interventions: Metronidazole
First posted: 2010-10-18
Last updated: 2014-02-06
Results first posted: 2013-12-18

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Area Under the Curve at Steady State	pre-dose: 30 min; post-dose:10 min, 3-4,6-8, 12-13, 24-25, 36-37, 48-49, 72-73 hours post dose	Area under the curve at steady state (AUCss)
Primary	Loading Dose Maximum Concentration	2-5 days of study drug administration	Loading Dose Maximum concentration (Cmax)
Primary	Loading Dose Minimum Concentration	2-5 days of study drug administration	Loading Dose Minimum Concentration (mg/L)
Primary	Multiple Dose Maximum Concentration	2-5 days of study drug administration	Multiple Dose Maximum Concentration (mg/L)
Primary	Multiple Dose Minimum Concentration	2-5 days of study drug administration	Multiple Dose Minimum Concentration (mg/L)
Primary	Clearance	2-5 days of study drug administration	Clearance (L/h/kg)
Primary	Volume of Distribution	2-5 days of study drug administration	Volume of Distribution (L/kg)

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Area Under the Curve at Steady State	pre-dose: 30 min; post-dose:10 min, 3-4,6-8, 12-13, 24-25, 36-37, 48-49, 72-73 hours post dose	The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate this PK parameter.	mg*hr/L	MEDIAN
PRIMARY	Loading Dose Maximum Concentration	2-5 days of study drug administration	The sample size contains the number of subjects that had the sample of interest collected.	mg/L	MEDIAN
PRIMARY	Loading Dose Minimum Concentration	2-5 days of study drug administration	The sample size contains the number of subjects that had the sample of interest collected.	mg/L	MEDIAN
PRIMARY	Multiple Dose Maximum Concentration	2-5 days of study drug administration	The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the multiple dose PK parameter.	mg/L	MEDIAN
PRIMARY	Multiple Dose Minimum Concentration	2-5 days of study drug administration	The sample size contains the number of subjects that had the sample of interest collected.	mg/L	MEDIAN
PRIMARY	Clearance	2-5 days of study drug administration	The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the PK parameter.	L/h/kg	MEDIAN
PRIMARY	Volume of Distribution	2-5 days of study drug administration	The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the PK parameter.	L/kg	MEDIAN

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Area Under the Curve at Steady State	Metronidazole IV	178.0	Full Range 66.0 to 472.0	mg*hr/L
Loading Dose Maximum Concentration	Metronidazole IV	16.54	Full Range 9.18 to 19.63	mg/L
Loading Dose Minimum Concentration	Metronidazole IV	9.20	Full Range 3.21 to 12.82	mg/L
Multiple Dose Maximum Concentration	Metronidazole IV	16.51	Full Range 8.71 to 34.05	mg/L
Multiple Dose Minimum Concentration	Metronidazole IV	11.62	Full Range 1.29 to 27.05	mg/L
Clearance	Metronidazole IV	0.043	Full Range 0.016 to 0.105	L/h/kg
Volume of Distribution	Metronidazole IV	0.99	Full Range 0.38 to 2.67	L/kg

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metronidazole IV	24
Overall Study	COMPLETED	Metronidazole IV	24
Overall Study	NOT COMPLETED	Metronidazole IV	0

Source ClinicalTrials.gov

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Endocrine disorders Adrenal Insufficiency	Endocrine disorders	Treatment	4	24
other	Convulsion	Nervous system disorders	Treatment	3	24
other	Dermatitis diaper	Skin and subcutaneous tissue disorders	Treatment	3	24
other	Other non-serious, infrequent adverse events	General disorders	Treatment	7	24
serious	Death	General disorders	Treatment	1	24
serious	Cardiac arrest	Cardiac disorders	Treatment	1	24
serious	Necrotising colitis	Gastrointestinal disorders	Treatment	2	24
serious	Patent ductus arteriosus repair	Surgical and medical procedures	Treatment	1	24
serious	Septic shock	Infections and infestations	Treatment	1	24
serious	Renal failure acute	Renal and urinary disorders	Treatment	1	24

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment
Total, other adverse events	Treatment	17	24
Total, serious adverse events	Treatment	5	24

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23587979	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01222585

GET https://conductscience.org/api/trials/v1/NCT01222585/registered

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