InfectionPhase 1NCT01441206
Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
A Phase 1 study testing rifampin in people with Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to learn more about the safety and dosing of rifampin in infants. Read more about this study
- Who is it for?
- Ages Up to 121 days
- Conditions the study is for
- Infection
- What is being tested?
- rifampin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 2012
- Phase
- Phase 1
- 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 121 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Cohort 1:
- History of allergic reactions to rifampin
- Aspartate aminotransferase (AST) greater than 3 times upper limit of normal
- Alanine aminotransferase (ALT) greater than 3 times upper limit of normal
- Serum creatinine greater than 1.7 mg.dL
- Urine output < 0.5 mL/hr/kg over the prior 24 hours
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- Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
- Cohort 2:
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7596
About this study
The purpose of this study is to learn more about the safety and dosing of rifampin in infants.
Read the detailed description
Pharmacokinetics and safety of rifampin will be studied in term and preterm infants who are receiving rifampin per standard of care.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rifampinDrug
Infants who will be receiving up to 4 doses of rifampin per protocol(Cohort 1)
Cohort 1:
Dosing will be as follows:
GA at birth < 32 weeks - PNA < 14 days: 10 mg/kg QD GA at birth < 32 weeks - PNA ≥ 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA < 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA ≥ 14 days: 20 mg/kg QD
| Study group | Role | What they receive |
|---|---|---|
| rifampin | Other | Cohort 1 will include infants who will be receiving up to 4 doses rifampin per study protocol. Receives: Drug: rifampin |
| rifampin per standard of care | No intervention | Cohort 2: Receiving rifampin per standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve 0-24 hours for rifampin
Measured: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Peak plasma concentration of rifampin
Measured: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Clearance of rifampin
Measured: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Volume of distribution at steady state
Measured: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Half life of rifampin
Measured: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Secondary outcomes (1)
Number of subjects with adverse events as a measure of safety and tolerability.
Measured: From the time of the first dose to 3 days after the last dose; serious adverse events will be collected from the first dose of rifampin to 7 days after the last dose of rifampin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Study to be redesigned.
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 University of North Carolina, Chapel HillThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Matthew M. Laughon, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441206
- Sponsor's protocol ID
- 10-2314
- Other IDs
- 1K23HD068497-01
- Status last verified
- Sep 2012
- First submitted
- 19 Sep 2011
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
- ClinicalTrials.gov ID
- NCT01441206
- Acronym / sponsor ID
- 10-2314
- Conditions
- Infection
- Keywords
- rifampin, infants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study to be redesigned.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Sep 2011 (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 study is to learn more about the safety and dosing of rifampin in infants.
Detailed description
Pharmacokinetics and safety of rifampin will be studied in term and preterm infants who are receiving rifampin per standard of care.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rifampin | Other | Drug: rifampinCohort 1 will include infants who will be receiving up to 4 doses rifampin per study protocol. |
| rifampin per standard of care | No intervention | –Cohort 2: Receiving rifampin per standard of care |
Who may qualify
- Ages
- Up to 121 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- History of allergic reactions to rifampin
- Aspartate aminotransferase (AST) greater than 3 times upper limit of normal
- Alanine aminotransferase (ALT) greater than 3 times upper limit of normal
- Serum creatinine greater than 1.7 mg.dL
- Urine output < 0.5 mL/hr/kg over the prior 24 hours
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 |
|---|---|---|
| rifampinInfants who will be receiving up to 4 doses of rifampin per protocol(Cohort 1) Cohort 1: Dosing will be as follows: GA at birth < 32 weeks - PNA < 14 days: 10 mg/kg QD GA at birth < 32 weeks - PNA ≥ 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA < 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA ≥ 14 days: 20 mg/kg QD | Drug | rifampin |
Primary outcome
Area under the plasma concentration versus time curve 0-24 hours for rifampin
Time frame: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Peak plasma concentration of rifampin
Time frame: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Clearance of rifampin
Time frame: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Volume of distribution at steady state
Time frame: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Half life of rifampin
Time frame: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
1 secondary outcome
Number of subjects with adverse events as a measure of safety and tolerability.
Time frame: From the time of the first dose to 3 days after the last dose; serious adverse events will be collected from the first dose of rifampin to 7 days after the last dose of rifampin.
Results and safety
The study was stopped early (reason given: Study to be redesigned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 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.
Matthew M. Laughon, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rifampin in people with Infection, run by University of North Carolina, Chapel Hill at 1 site 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 0 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study to be redesigned.). Results are not available in the source record.
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.
What does the primary outcome measure?
Area under the plasma concentration versus time curve 0-24 hours for rifampin (time frame: Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 14 Sep 2012.