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The Role of Short-course Ceftriaxone Therapy in the Treatment of Severe Nontyphoidal Salmonella Enterocolitis

Primary Purpose

Diarrhea

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
ceftriaxone
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring nontyphoidal salmonellae, enterocolitis, ceftriaxone

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with suspected severe Salmonella enterocolitis
  • defined as those with a high fever (core body temperature ≥ 38.5℃) persisting for longer than 48 hours
  • diarrhea with mucous and bloody-tinged stool.

Exclusion Criteria:

  • Children with a toxic appearance, severe vomiting and abdominal distension
  • suggestive of sepsis or toxic megacolon, those with an increased risk of invasive NTS diseases
  • immunosuppressive illnesses
  • had taken antibiotics during the 7 days before the visit will be excluded.

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ceftriaxone

Arm Description

Outcomes

Primary Outcome Measures

To evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe NTS enterocolitis in children and the excretion of Salmonella in feces.
Patients will be separated into 2 groups. One is treated with parenteral ceftriaxone and the other is treated with supportive drugs. Then we evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe NTS enterocolitis in children and the excretion of Salmonella in feces.

Secondary Outcome Measures

PCR detection will be used for Salmonella in stool samples.
Patients will be randomly separated into 2 groups. One is treated with ceftriaxone and the other is treated with supportive drugs. Then we will evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe NTS enterocolitis in children and the excretion of Salmonella in feces.

Full Information

First Posted
November 25, 2010
Last Updated
January 14, 2011
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01278017
Brief Title
The Role of Short-course Ceftriaxone Therapy in the Treatment of Severe Nontyphoidal Salmonella Enterocolitis
Official Title
The Role of Short-course Ceftriaxone Therapy in the Treatment of Severe Nontyphoidal Salmonella Enterocolitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the investigators study is to evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe nontyphoidal Salmonella enterocolitis in children and the excretion of Salmonella in feces.
Detailed Description
Nontyphoidal salmonellae (NTS) is one of the most important pathogens of gastroenteritis in humans. Although most nontyphoidal Salmonella infections result in self-limited gastroenteritis, invasive infections such as bacteremia, meningitis or extraintestinal infection could also occur. Antimicrobial therapy is not recommended for routine treatment of nontyphoidal salmonellosis and effective antibiotic treatment is essential if NTS infection spreads beyond the intestine such as bacteremia, meningitis or osteomyelitis. Although some reports revealed that antimicrobial therapy may be beneficial for shortening the clinical courses of severe NTS enterocolitis, most of them were based on clinical observations, not based on the results of objective examinations. Thus, the use of antibiotics in the treatment of patients with severe NTS gastroenteritis is still controversial in clinical practice. As a third generation cephalosporin, ceftriaxone has a higher concentration than conventional antibiotics such as ampicillin and trimethoprim-sulfamethoxazole in the intestinal mucosa and gallbladder. Besides, ceftriaxone maintains relatively lower resistance rate in Salmonella than those of other conventional antibiotics. So the purpose of our study is to evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe NTS enterocolitis in children and the excretion of Salmonella in feces. The investigators think that the study may be helpful for clinicians in the treatment of severe NTS enterocolitis in children, especially on the judgments of the choices and the treatment cures of antibiotics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
nontyphoidal salmonellae, enterocolitis, ceftriaxone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ceftriaxone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ceftriaxone
Other Intervention Name(s)
Rocephine
Intervention Description
ceftriaxone ,parenteral route, 50mg/kg/day divided twice
Primary Outcome Measure Information:
Title
To evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe NTS enterocolitis in children and the excretion of Salmonella in feces.
Description
Patients will be separated into 2 groups. One is treated with parenteral ceftriaxone and the other is treated with supportive drugs. Then we evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe NTS enterocolitis in children and the excretion of Salmonella in feces.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
PCR detection will be used for Salmonella in stool samples.
Description
Patients will be randomly separated into 2 groups. One is treated with ceftriaxone and the other is treated with supportive drugs. Then we will evaluate if short-course of ceftriaxone therapy could shorten the clinical courses of severe NTS enterocolitis in children and the excretion of Salmonella in feces.
Time Frame
Three month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with suspected severe Salmonella enterocolitis defined as those with a high fever (core body temperature ≥ 38.5℃) persisting for longer than 48 hours diarrhea with mucous and bloody-tinged stool. Exclusion Criteria: Children with a toxic appearance, severe vomiting and abdominal distension suggestive of sepsis or toxic megacolon, those with an increased risk of invasive NTS diseases immunosuppressive illnesses had taken antibiotics during the 7 days before the visit will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming_Han Tsai, MD
Phone
886-2-24313131
Ext
2626
Email
drtsai1208@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming_Han Tsai, MD
Organizational Affiliation
Chang Gung Memorial Hospital, Keelung, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming_Han Tsai, MD
Phone
886-2-24313131
Ext
2626
Email
drtsai1208@gmail.com
First Name & Middle Initial & Last Name & Degree
Ming_Han Tsai, MD

12. IPD Sharing Statement

Learn more about this trial

The Role of Short-course Ceftriaxone Therapy in the Treatment of Severe Nontyphoidal Salmonella Enterocolitis

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