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

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.

Study Overview

• Status: Unknown
• Conditions: Diarrhea
• Intervention / Treatment: Drug: ceftriaxone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ming_Han Tsai, MD; Phone Number: 2626 886-2-24313131; Email: drtsai1208@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Ming_Han Tsai, MD; Phone Number: 2626 886-2-24313131; Email: drtsai1208@gmail.com
    • Principal Investigator: Ming_Han Tsai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ceftriaxone	Drug: ceftriaxone; ceftriaxone ,parenteral route, 50mg/kg/day divided twice; Other Names: Rocephine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three month

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Ming_Han Tsai, MD, Chang Gung Memorial Hospital, Keelung, Taiwan

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: November 25, 2010
• First Submitted That Met QC Criteria: January 14, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): January 17, 2011
• Last Update Submitted That Met QC Criteria: January 14, 2011
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: ceftriaxone; nontyphoidal salmonellae; enterocolitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Diarrhea; Enterocolitis; Anti-Infective Agents; Anti-Bacterial Agents; Ceftriaxone
• Other Study ID Numbers: CMRPG290361