NCT00386789

Brief Summary

Typhoid fever remains an important cause of morbidity and mortality in the developing world. It is estimated that more than 16 million cases and about 600,000 deaths occur annually, most of which occur in Southeast Asia and Africa. Ingestion of food or water contaminated by acutely infected persons or chronic carriers is the most common form of transmission. As a result, typhoid fever is prevalent where unsafe drinking water or contaminated food is common. Typhoid fever is highly endemic in Vietnam, especially in the southern provinces and is a significant disease in both preschool and school-aged children. Data from Dong Thap Provincial Hospital, Mekong delta region showed that among 3,934 hospitalized typhoid fever cases from 1990 to 1995, 4.2% had complications and 0.8% died. Typhoid fever has become difficult and expensive to treat. About 90% of Salmonella typhi isolates are of multidrug-resistant (resistant to chloramphenicol, ampicillin, and trimethoprim-sulfamethoxazole) and 76% of isolates showed reduced susceptibility to fluoroquinolones. Isolates with full fluoroquinolone or extended spectrum cephalosporin resistance have not yet reported in Vietnam but occur sporadically in the Indian subcontinent. If they become widespread, alternative treatment options will be limited. The improvement of sanitation, provision of safe water and elimination of chronic carriage is not expected to be achieved quickly. Accordingly, vaccination against typhoid fever is increasingly important national public health priority.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2006

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2008

Completed
Last Updated

July 2, 2017

Status Verified

June 17, 2008

First QC Date

October 11, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Typhoid FeverSerological SurveyFollow-UpProtection

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects who were involved in the Phase III trial, OH98-CH-N002.

You may not qualify if:

  • Not specified.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National Institute of Child Health and Human Development (NICHD), 9000 Rockville

Bethesda, Maryland, 20892, United States

Location

Dong Thap Provincial Hospital

Dong Thập, Vietnam

Location

National Institute of Hygiene and Epidemiology

Hanoi, Vietnam

Location

Pasteur Institute

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

  • Smith MD, Duong NM, Hoa NT, Wain J, Ha HD, Diep TS, Day NP, Hien TT, White NJ. Comparison of ofloxacin and ceftriaxone for short-course treatment of enteric fever. Antimicrob Agents Chemother. 1994 Aug;38(8):1716-20. doi: 10.1128/AAC.38.8.1716.

    PMID: 7986000BACKGROUND

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella InfectionsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections
0

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

October 11, 2006

First Posted

October 12, 2006

Study Start

October 5, 2006

Study Completion

June 17, 2008

Last Updated

July 2, 2017

Record last verified: 2008-06-17

Locations