The Role of Short-course Ceftriaxone Therapy in the Treatment of Severe Nontyphoidal Salmonella Enterocolitis
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ClinicalTrials.gov Identifier: NCT01278017 |
Recruitment Status : Unknown
Verified November 2010 by Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : January 17, 2011
Last Update Posted : January 17, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diarrhea | Drug: ceftriaxone | Phase 4 |
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 (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 |

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

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Ages Eligible for Study: | 3 Months to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278017
Contact: Ming_Han Tsai, MD | 886-2-24313131 ext 2626 | drtsai1208@gmail.com |
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 |
Principal Investigator: | Ming_Han Tsai, MD | Chang Gung Memorial Hospital, Keelung, Taiwan |
Responsible Party: | Tsai Ming-Han, Chang Gung Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT01278017 |
Other Study ID Numbers: |
CMRPG290361 |
First Posted: | January 17, 2011 Key Record Dates |
Last Update Posted: | January 17, 2011 |
Last Verified: | November 2010 |
nontyphoidal salmonellae enterocolitis ceftriaxone |
Enterocolitis Diarrhea Signs and Symptoms, Digestive Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Ceftriaxone Anti-Bacterial Agents Anti-Infective Agents |