Listeria MonocytogenesNCT03248973
Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester
An observational study of Listeria Monocytogenes, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester of Pregnancy Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Listeria Monocytogenes
- What is being tested?
- Ampicillin Injection
- Type of treatment
- Injection or infusion
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Apr 2017to 2 Feb 2018
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: One pregnant woman with listeria monocytogenes bacteremia in the first trimester
Who may be able to join
- One pregnant woman with listeria monocytogenes bacteremia in the first trimester
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester of Pregnancy: a Case Report and Review of Literatures
Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester of Pregnancy
Read the detailed description
A 34-year-old nulliparous woman with 11 gestational weeks with flu-like illness was proved to be infection by Listeria monocytogenes, and then treated by intravenous ampicillin 2 g every 4 hours for 3 weeks. A healthy unaffected male baby was delivered at 41 weeks' gestation.
- Conditions
- Listeria Monocytogenes
- Being tested
- Ampicillin Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ampicillin InjectionDrug
Ampicillin injection 2 g q4h for 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful treatment
A favorable outcome of maternal listeria infection in the first trimester may be anticipated. Besides, intravenous ampicillin with or without gentamicin should be a reasonable treatment option for maternal listeria infection in the first trimester.
Measured: 1 month after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start3 Apr 2017
- Primary completion8 Jan 2018
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Listeria MonocytogenesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248973
- Sponsor's protocol ID
- 106030-C
- Status last verified
- Feb 2019
- First submitted
- 10 Aug 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester of Pregnancy: a Case Report and Review of Literatures
- ClinicalTrials.gov ID
- NCT03248973
- Acronym / sponsor ID
- 106030-C
- Conditions
- Listeria Monocytogenes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 15 Aug 2017 (actual)
- 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.
Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester of Pregnancy
Detailed description
A 34-year-old nulliparous woman with 11 gestational weeks with flu-like illness was proved to be infection by Listeria monocytogenes, and then treated by intravenous ampicillin 2 g every 4 hours for 3 weeks. A healthy unaffected male baby was delivered at 41 weeks' gestation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One pregnant woman with listeria monocytogenes bacteremia in the first trimester
Key inclusion criteria (1 listed)
- One pregnant woman with listeria monocytogenes bacteremia in the first trimester
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ampicillin InjectionAmpicillin injection 2 g q4h for 3 weeks | Drug | – |
Primary outcome
Successful treatment
Time frame: 1 month after delivery
A favorable outcome of maternal listeria infection in the first trimester may be anticipated. Besides, intravenous ampicillin with or without gentamicin should be a reasonable treatment option for maternal listeria infection in the first trimester.
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 12 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Listeria Monocytogenes, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 0 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 12 Feb 2019. 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 Taiwan. 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?
Successful treatment (time frame: 1 month after 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 12 Feb 2019.