Drug Metabolism During PregnancyNCT02427932
Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients
An observational study of Drug Metabolism During Pregnancy, run by Stanford University at 1 site in United States.
Trial summary
This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women to that of non-pregnant women; the placental transfer over time; and the subsequent metabolism of the transferred drug(s) in the neonate. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Drug Metabolism During Pregnancy
- What is being tested?
- Ampicillin, Ampicillin and Gentamicin and Gentamicin
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jan 2017
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Women receiving ampicillin or gentamicin
Who may be able to join
- Generally healthy, pregnant woman (28-42 weeks)
- Generally healthy, non-pregnant female
- Scheduled to receive Ampicillin and/or Gentamicin IV
- Ages 18-55 years old
- Relatively normal Comprehensive Metabolic Panel (if available), as evidenced by recent blood work
- Able and willing to sign consent
Who cannot join
- Women with known renal or hepatic impairment; preeclampsia; Diabetes, including Gestational; any medical condition that, in the opinion of the Investigator or research team member, could potentially interfere with the study objectives
- Women who are participating in another study
- Pregnant with multiples
- BMI > 40
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucille Packard Children's Hospital
Palo Alto, California, 94304
About this study
Official title: PK and PD Modeling of Ampicillin and Gentamicin in Peripartum Patients
This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women to that of non-pregnant women; the placental transfer over time; and the subsequent metabolism of the transferred drug(s) in the neonate.
Read the detailed description
Pregnant women who present to Labor and Delivery will be identified as potential participants based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy. The additional group of 20 non-pregnant women will also be identified based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy.
Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained.
Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery; or Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs. Dose times will be recorded.
Non-pregnant participants will receive similar doses of either Ampicillin and/or Gentamicin, if not the same dose(s).
Fingerstick blood collection will be drawn from both populations at the following timepoints:
- before the administration of Ampicillin, and/or
- before the administration of Gentamicin
- after the full initial dose of the antibiotic has infused, at 5 min, 15 min, 30 min, 2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY (a 5 minute window for each timepoint will be permitted) If delivery occurs prior to the 3 or 6 hr timepoints, fingerstick blood collection should continue
Samples will be obtained on filter paper via the Dry Blood Spot (DBS) method, which is clinically appropriate for the purposes of this study.
Umbilical venous and arterial blood will also be drawn for sampling from the placenta after delivery, and cutting of the umbilical cord.
- Conditions
- Drug Metabolism During Pregnancy
- Being tested
- Ampicillin, Ampicillin and Gentamicin, Gentamicin
- Keywords
- Pharmacokinetics (PK), Pharmacodynamics (PD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmpicillinDrug
Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery for Group B Strep prophylaxis; non-pregnant participants will receive Ampicillin for qualifying diagnosis
Ampicillin and GentamicinDrug
Pregnant participants will receive Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs for chorioamnionitis; non-pregnant participants will receive for qualifying diagnosis
GentamicinDrug
Prescribed to non-pregnant participants
| Study group | Role | What they receive |
|---|---|---|
| Pregnant/Ampicillin | pregnant participants who will receive Ampicillin for conditions such as Group B Streptococcus Receives: Drug: Ampicillin | |
| Non-pregnant/Ampicillin | non-pregnant participants who will receive Ampicillin for a qualifying hospital admission Receives: Drug: Ampicillin | |
| Pregnant and Non-pregnant/Ampicillin and Gentamicin | pregnant participants who will receive Ampicillin and Gentamicin for conditions such as chorioamnionitis; non-pregnant participants who will receive Ampicillin and Gentamicin for a qualifying hospital admission Receives: Drug: Ampicillin and Gentamicin | |
| Non-Pregnant/Gentamicin | non-pregnant participants who will receive Gentamicin for a qualifying hospital admission Receives: Drug: Gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Profiling to Measure Maternal Metabolism of Ampicillin and/or Gentamicin in Pregnancy
blood samples will be taken at the above timepoints; data analysis of all specimens will begin approx. 12-15 months from start of study
Measured: predose; after the full initial dose of the antibiotic has infused, at 5min, 15min, 30min, 2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY
Secondary outcomes (2)
Profile of Neonatal Metabolism of Ampicillin and Gentamicin That Crosses the Placental Barrier
blood samples to be drawn at the above timepoint; data analysis of all specimens will begin approx. 12-15 months from start of study
Measured: At delivery/upon cutting of umbilical cord
PD Modeling of Peripartum Patients Receiving Ampicillin and/or Gentamicin
subject will be observed for adverse events related to drug administration
Measured: predose; while dosing; post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Metabolism During PregnancyStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- David Drover, MD
- Responsible party
- Principal investigator, Brendan Carvalho, Stanford University
- Investigators
- Brendan Carvalho, MBBCh, Study director, Stanford UniversityDavid Drover, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427932
- Sponsor's protocol ID
- 29664
- Status last verified
- May 2017
- First submitted
- 14 Apr 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PK and PD Modeling of Ampicillin and Gentamicin in Peripartum Patients
- ClinicalTrials.gov ID
- NCT02427932
- Acronym / sponsor ID
- 29664
- Conditions
- Drug Metabolism During Pregnancy
- Keywords
- Pharmacokinetics (PK), Pharmacodynamics (PD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- David Drover, MD
- Study start
- May 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 Apr 2015 (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.
This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women to that of non-pregnant women; the placental transfer over time; and the subsequent metabolism of the transferred drug(s) in the neonate.
Detailed description
Pregnant women who present to Labor and Delivery will be identified as potential participants based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy. The additional group of 20 non-pregnant women will also be identified based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy.
Once identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained.
Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery; or Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs. Dose times will be recorded.
Non-pregnant participants will receive similar doses of either Ampicillin and/or Gentamicin, if not the same dose(s).
Fingerstick blood collection will be drawn from both populations at the following timepoints:
- before the administration of Ampicillin, and/or
- before the administration of Gentamicin
- after the full initial dose of the antibiotic has infused, at 5 min, 15 min, 30 min, 2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY (a 5 minute window for each timepoint will be permitted) If delivery occurs prior to the 3 or 6 hr timepoints, fingerstick blood collection should continue
Samples will be obtained on filter paper via the Dry Blood Spot (DBS) method, which is clinically appropriate for the purposes of this study.
Umbilical venous and arterial blood will also be drawn for sampling from the placenta after delivery, and cutting of the umbilical cord.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant/Ampicillin | – | Drug: Ampicillinpregnant participants who will receive Ampicillin for conditions such as Group B Streptococcus |
| Non-pregnant/Ampicillin | – | Drug: Ampicillinnon-pregnant participants who will receive Ampicillin for a qualifying hospital admission |
| Pregnant and Non-pregnant/Ampicillin and Gentamicin | – | Drug: Ampicillin and Gentamicinpregnant participants who will receive Ampicillin and Gentamicin for conditions such as chorioamnionitis; non-pregnant participants who will receive Ampicillin and Gentamicin for a qualifying hospital admission |
| Non-Pregnant/Gentamicin | – | Drug: Gentamicinnon-pregnant participants who will receive Gentamicin for a qualifying hospital admission |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women receiving ampicillin or gentamicin
Key inclusion criteria (6 listed)
- Generally healthy, pregnant woman (28-42 weeks)
- Generally healthy, non-pregnant female
- Scheduled to receive Ampicillin and/or Gentamicin IV
- Ages 18-55 years old
- Relatively normal Comprehensive Metabolic Panel (if available), as evidenced by recent blood work
Key exclusion criteria (4 listed)
- Women with known renal or hepatic impairment; preeclampsia; Diabetes, including Gestational; any medical condition that, in the opinion of the Investigator or research team member, could potentially interfere with the study objectives
- Women who are participating in another study
- Pregnant with multiples
- BMI > 40
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 |
|---|---|---|
| AmpicillinPregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery for Group B Strep prophylaxis; non-pregnant participants will receive Ampicillin for qualifying diagnosis | Drug | Non-pregnant/Ampicillin, Pregnant/Ampicillin |
| Ampicillin and GentamicinPregnant participants will receive Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs for chorioamnionitis; non-pregnant participants will receive for qualifying diagnosis | Drug | Pregnant and Non-pregnant/Ampicillin and Gentamicin |
| GentamicinPrescribed to non-pregnant participants | Drug | Non-Pregnant/Gentamicin |
Primary outcome
Pharmacokinetic Profiling to Measure Maternal Metabolism of Ampicillin and/or Gentamicin in Pregnancy
Time frame: predose; after the full initial dose of the antibiotic has infused, at 5min, 15min, 30min, 2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY
blood samples will be taken at the above timepoints; data analysis of all specimens will begin approx. 12-15 months from start of study
2 secondary outcomes
Profile of Neonatal Metabolism of Ampicillin and Gentamicin That Crosses the Placental Barrier
Time frame: At delivery/upon cutting of umbilical cord
PD Modeling of Peripartum Patients Receiving Ampicillin and/or Gentamicin
Time frame: predose; while dosing; post dose
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 10 May 2017.
Related trials for Drug Metabolism During Pregnancy
RecruitingObservational study
Bempedoic Acid Pregnancy Surveillance Program
Pregnancy, Hyperlipidemias
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.
Brendan Carvalho, MBBCh study director
Stanford University
David Drover, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Metabolism During Pregnancy, run by Stanford University 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 6 inclusion and 4 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 10 May 2017. 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.
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.
What does the primary outcome measure?
Pharmacokinetic Profiling to Measure Maternal Metabolism of Ampicillin and/or Gentamicin in Pregnancy (time frame: predose; after the full initial dose of the antibiotic has infused, at 5min, 15min, 30min, 2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY). 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 10 May 2017.