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

• ClinicalTrials.gov Identifier: NCT01278017
• Recruitment Status: Unknown
• First Posted: January 17, 2011
• Last Update Posted: January 17, 2011
• Sponsor: Chang Gung Memorial Hospital
• Information provided by: Chang Gung Memorial Hospital

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.

Condition or disease	Intervention/treatment	Phase
Diarrhea	Drug: ceftriaxone	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Role of Short-course Ceftriaxone Therapy in the Treatment of Severe Nontyphoidal Salmonella Enterocolitis
• Study Start Date: August 2010
• Estimated Primary Completion Date: June 2011
• Estimated Study Completion Date: July 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: ceftriaxone	Drug: ceftriaxone; ceftriaxone ,parenteral route, 50mg/kg/day divided twice; Other Name: Rocephine

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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 :

1. PCR detection will be used for Salmonella in stool samples. [ Time Frame: Three month ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 3 Months to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Tsai Ming-Han, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT01278017
• Other Study ID Numbers: CMRPG290361
• First Posted: January 17, 2011
• Last Update Posted: January 17, 2011
• Last Verified: November 2010

Keywords provided by Chang Gung Memorial Hospital:

nontyphoidal salmonellae; enterocolitis; ceftriaxone

Additional relevant MeSH terms:

Enterocolitis; Diarrhea; Signs and Symptoms, Digestive; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ceftriaxone; Anti-Bacterial Agents; Anti-Infective Agents