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
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring nontyphoidal salmonellae, enterocolitis, ceftriaxone
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.
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
NCT ID
NCT01278017
First Posted
November 25, 2010
Last Updated
January 14, 2011
Sponsor
Chang Gung Memorial Hospital
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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