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

NCT01278017 | Unknown Phase 4 DMC

• 1 other identifier: CMRPG290361
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Keywords

nontyphoidal salmonellae; enterocolitis; ceftriaxone

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• PCR detection will be used for Salmonella in stool samples.

  Three month

Study Arms (1)

ceftriaxone

EXPERIMENTAL

Drug: ceftriaxone

Interventions

ceftriaxone DRUG

ceftriaxone ,parenteral route, 50mg/kg/day divided twice

Also known as: Rocephine

ceftriaxone

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Diarrhea; Enterocolitis

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ming_Han Tsai, MD

  Chang Gung Memorial Hospital, Keelung, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming_Han Tsai, MD

CONTACT

886-2-24313131; drtsai1208@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2010
• First Posted: January 17, 2011
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2012
• Last Updated: January 17, 2011

Record last verified: 2010-11

Locations

TW (1)