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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01278017
First received: November 25, 2010
Last updated: January 14, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Diarrhea
Drug: ceftriaxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Short-course Ceftriaxone Therapy in the Treatment of Severe Nontyphoidal Salmonella Enterocolitis

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

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. [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Three month ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: August 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ceftriaxone Drug: ceftriaxone
ceftriaxone ,parenteral route, 50mg/kg/day divided twice
Other Name: Rocephine

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.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278017

Contacts
Contact: Ming_Han Tsai, MD 886-2-24313131 ext 2626 drtsai1208@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Ming_Han Tsai, MD    886-2-24313131 ext 2626    drtsai1208@gmail.com   
Principal Investigator: Ming_Han Tsai, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Ming_Han Tsai, MD Chang Gung Memorial Hospital, Keelung, Taiwan
  More Information

No publications provided

Responsible Party: Tsai Ming-Han, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01278017     History of Changes
Other Study ID Numbers: CMRPG290361
Study First Received: November 25, 2010
Last Updated: January 14, 2011
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
nontyphoidal salmonellae
enterocolitis
ceftriaxone

Additional relevant MeSH terms:
Enterocolitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014