InfectionNCT00491426
Antimicrobial PK in Infants With Suspected or Confirmed Infection
An observational study of Infection, run by Duke University at 6 sites in United States.
Trial summary
The purpose of this protocol is to provide a mechanism for the ongoing collection of blood and urine samples in newborns that will be used to measure levels of antimicrobial products used in the newborn population where there are limited pharmacokinetic data in either premature or term infants. Read more about this study
- Who is it for?
- Ages Up to 120 days
- Conditions the study is for
- Infection
- What is being tested?
- Ampicillin, Metronidazole and Piperacillin/Tazobactam
- How many people
- 450 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2006to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 days
- All sexes
- No healthy volunteers
- Child
Study population: Premature infants <32 weeks gestational age at birth at risk of infections.
Who may be able to join
- Infants ≤32 weeks and 6 days EGA with high probability of receiving one of the antimicrobial agents listed are eligible for study.
- Age younger than 120 days
- Written informed consent from parent or legal guardian
- Infants likely to survive beyond 48 hours after enrollment
Who cannot join
- Failure to consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Children's Hospital of Michigan, Wayne State University
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27705
University of California at San Diego
La Jolla, California, 92103
Kosair Children's Hospital
Louisville, Kentucky, 40202
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Antimicrobial Pharmacokinetics in High Risk Infants (Urinary Proteomics in Antimicrobial/Antifungal-Treated Newborns - add-on Study)
The purpose of this protocol is to provide a mechanism for the ongoing collection of blood and urine samples in newborns that will be used to measure levels of antimicrobial products used in the newborn population where there are limited pharmacokinetic data in either premature or term infants.
Read the detailed description
Greater than 90% of infants born <32 weeks admitted to critical care nurseries are treated with antimicrobial agents during their NICU hospitalization. Most antimicrobial products used in the neonatal population lack some aspect of pharmacokinetic information specific to neonates. Dosing is based largely on pharmacokinetic data from older children or in some cases, adults. This study will also establish a bank of urine samples from newborns treated with antimicrobial and/or antifungal therapy and to characterize the urinary proteome in selected samples. The sites of the NIH-sponsored Pediatric Pharmacology Research Network (PPRU) have access to appropriate assays using microliter amounts of serum and a large pool of potential subjects to generate meaningful data that will
- Guide dosing of commonly used antimicrobial agents, and
- Provide preliminary data for future industry and government trials in the nursery.
- Conditions
- Infection
- Being tested
- Ampicillin, Metronidazole, Piperacillin/Tazobactam, Acyclovir, Amphotericin B
- Keywords
- Infection, Anti-Infective Agents, Antifungal Agents, Proteomics
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmpicillinDrug
Drug prescribed per routine medical care.
MetronidazoleDrug
Drug prescribed per routine medical care.
Piperacillin/TazobactamDrug
Drug prescribed per routine medical care.
AcyclovirDrug
Drug prescribed per routine medical care.
Amphotericin BDrug
Drug prescribed per routine medical care.
AmbisomeDrug
Drug prescribed per routine medical care.
AnidulafunginDrug
Drug prescribed per routine medical care.
CaspofunginDrug
Drug prescribed per routine medical care.
| Study group | Role | What they receive |
|---|---|---|
| <26 weeks | Subjects <26 weeks gestational age Receives: Drug: Ampicillin; Drug: Metronidazole; Drug: Piperacillin/Tazobactam; Drug: Acyclovir; Drug: Amphotericin B; Drug: Ambisome; Drug: Anidulafungin; Drug: Caspofungin | |
| 26-29 weeks | Subjects 26-29 weeks gestational age Receives: Drug: Ampicillin; Drug: Metronidazole; Drug: Piperacillin/Tazobactam; Drug: Acyclovir; Drug: Amphotericin B; Drug: Ambisome; Drug: Anidulafungin; Drug: Caspofungin | |
| 30-32 weeks | Subjects 30-32 weeks gestational age Receives: Drug: Ampicillin; Drug: Metronidazole; Drug: Piperacillin/Tazobactam; Drug: Acyclovir; Drug: Amphotericin B; Drug: Ambisome; Drug: Anidulafungin; Drug: Caspofungin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startJan 2006
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Pharmacology Research Units Network
- Responsible party
- Sponsor
- Investigators
- Danny Benjamin, MD, Principal investigator, PPRUMary Jayne Kennedy, Pharm, D, Principal investigator, Louisville-PPRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491426
- Sponsor's protocol ID
- Pro00015379
- Other IDs
- PPRU 10824
- Status last verified
- Nov 2012
- First submitted
- 22 Jun 2007
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Pharmacokinetics in High Risk Infants (Urinary Proteomics in Antimicrobial/Antifungal-Treated Newborns - add-on Study)
- ClinicalTrials.gov ID
- NCT00491426
- Acronym / sponsor ID
- Pro00015379
- Conditions
- Infection
- Keywords
- Infection, Anti-Infective Agents, Antifungal Agents, Proteomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pediatric Pharmacology Research Units Network
- Study start
- Jan 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to provide a mechanism for the ongoing collection of blood and urine samples in newborns that will be used to measure levels of antimicrobial products used in the newborn population where there are limited pharmacokinetic data in either premature or term infants.
Detailed description
Greater than 90% of infants born <32 weeks admitted to critical care nurseries are treated with antimicrobial agents during their NICU hospitalization. Most antimicrobial products used in the neonatal population lack some aspect of pharmacokinetic information specific to neonates. Dosing is based largely on pharmacokinetic data from older children or in some cases, adults. This study will also establish a bank of urine samples from newborns treated with antimicrobial and/or antifungal therapy and to characterize the urinary proteome in selected samples. The sites of the NIH-sponsored Pediatric Pharmacology Research Network (PPRU) have access to appropriate assays using microliter amounts of serum and a large pool of potential subjects to generate meaningful data that will
- Guide dosing of commonly used antimicrobial agents, and
- Provide preliminary data for future industry and government trials in the nursery.
Study design
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| <26 weeks | – | Drug: Ampicillin, Drug: Metronidazole, Drug: Piperacillin/Tazobactam, Drug: Acyclovir, Drug: Amphotericin B, Drug: Ambisome, Drug: Anidulafungin, Drug: CaspofunginSubjects <26 weeks gestational age |
| 26-29 weeks | – | Drug: Ampicillin, Drug: Metronidazole, Drug: Piperacillin/Tazobactam, Drug: Acyclovir, Drug: Amphotericin B, Drug: Ambisome, Drug: Anidulafungin, Drug: CaspofunginSubjects 26-29 weeks gestational age |
| 30-32 weeks | – | Drug: Ampicillin, Drug: Metronidazole, Drug: Piperacillin/Tazobactam, Drug: Acyclovir, Drug: Amphotericin B, Drug: Ambisome, Drug: Anidulafungin, Drug: CaspofunginSubjects 30-32 weeks gestational age |
Who may qualify
- Ages
- Up to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature infants <32 weeks gestational age at birth at risk of infections.
Key inclusion criteria (4 listed)
- Infants ≤32 weeks and 6 days EGA with high probability of receiving one of the antimicrobial agents listed are eligible for study.
- Age younger than 120 days
- Written informed consent from parent or legal guardian
- Infants likely to survive beyond 48 hours after enrollment
Key exclusion criteria (1 listed)
- Failure to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmpicillinDrug prescribed per routine medical care. | Drug | 26-29 weeks, 30-32 weeks, <26 weeks |
| MetronidazoleDrug prescribed per routine medical care. | Drug | 26-29 weeks, 30-32 weeks, <26 weeks |
| Piperacillin/TazobactamDrug prescribed per routine medical care. | Drug | 26-29 weeks, 30-32 weeks, <26 weeks |
| AcyclovirDrug prescribed per routine medical care. | Drug | 26-29 weeks, 30-32 weeks, <26 weeks |
| Amphotericin BDrug prescribed per routine medical care. | Drug | 26-29 weeks, 30-32 weeks, <26 weeks |
| AmbisomeDrug prescribed per routine medical care. | Drug | 26-29 weeks, 30-32 weeks, <26 weeks |
| AnidulafunginDrug prescribed per routine medical care. | Drug | 26-29 weeks, 30-32 weeks, <26 weeks |
| CaspofunginDrug prescribed per routine medical care. | Drug | 26-29 weeks, 30-32 weeks, <26 weeks |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny Benjamin, MD principal investigator
PPRU
Mary Jayne Kennedy, Pharm, D principal investigator
Louisville-PPRU
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Duke University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2012.