Successful Treatment of Maternal Listeria Monocytogenes B... | NCT03248973

Studies
Successful Treatment of Maternal Listeria Monocytogenes Bacteremia in the First Trimester

NCT03248973

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Feb 12, 2019Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Listeria Monocytogenes

Interventions

Ampicillin Injection

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2017Actual

Primary Completion Date

Jan 8, 2018Actual

Completion Date

Feb 2, 2018Actual

First Submitted Date

Aug 10, 2017

First Submission Date that Met QC Criteria

Aug 10, 2017

First Posted Date

Aug 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2019

Last Update Posted Date

Feb 12, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Name	Type	Description	Arm Group Labels	Other Names
Ampicillin Injection	Drug	Ampicillin injection 2 g q4h for 3 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 month after delivery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

One pregnant woman with listeria monocytogenes bacteremia in the first trimester

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

One pregnant woman with listeria monocytogenes bacteremia in the first trimester

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital		New Taipei City		220	Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D000667	Ampicillin

Ancestor Terms

ID	Term
D010400	Penicillin G
D010406	Penicillins
D047090	beta-Lactams
D007769	Lactams
D000577

Browse Leaves

Not provided

Browse Branches

Not provided