drugset / Trial / NCT01618591
Trial Evaluating Ambulatory Treatment of Travelers' Diarrhea
Terminated
384 enrolled
Uniformed Services University of the Health Sciences
Ministry of Defence, United Kingdom · collabNaval Medical Research Center · collabNaval Medical Research Unit- 3 · collabNaval Medical Research Unit- 6 · collabNavy Bureau of Medicine and Surgery · collabUnited States Army Medical Unit - Kenya · collabUnited States Naval Medical Center, Portsmouth · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of the trial is to develop the evidence on relative efficacy of 3 available single-dose loperamide adjuncted regimens for watery diarrhea and a single-dose regimen, with and without loperamide, for dysentery/febrile diarrhea required for informing decisions among these regimens. Information from this study will be used to develop management guidelines for the diagnosis and management of travelers' diarrhea (TD) among deployed United States and United Kingdom military personnel.
Timeline
- Start
- 2012-09
- Primary completion
- 2016-03
- Completion
- 2016-03
Outcome
Outcome not reported
Stopped (Enrollment): “AWD arm was completed. ADF diarrhea arm was unable to fill completely and there are no funds remaining to continue recruiting/enrolling.”
Publications
- Johnson RC, Van Nostrand JD, Tisdale M, Swierczewski B, Simons MP, Connor P, Fraser J, Melton-Celsa AR, Tribble DR, Riddle MS. Fecal Microbiota Functional Gene Effects Related to Single-Dose Antibiotic Treatment of Travelers' Diarrhea. Open Forum Infect Dis. 2021 May 28;8(6):ofab271. doi: 10.1093/ofid/ofab271. eCollection 2021 Jun.
- Riddle MS, Connor P, Fraser J, Porter CK, Swierczewski B, Hutley EJ, Danboise B, Simons MP, Hulseberg C, Lalani T, Gutierrez RL, Tribble DR; TrEAT TD Study Team. Trial Evaluating Ambulatory Therapy of Travelers' Diarrhea (TrEAT TD) Study: A Randomized Controlled Trial Comparing 3 Single-Dose Antibiotic Regimens With Loperamide. Clin Infect Dis. 2017 Nov 29;65(12):2008-2017. doi: 10.1093/cid/cix693.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 500 mg | — |
| Subject | Azithromycin | Small molecule | 1000 mg | — |
| Subject | Levofloxacin | Small molecule | 500 mg | — |
| Subject | Loperamide | Small molecule | 2 mg | — |
| Subject | Rifaximin | Other / unclassified | 1650 mg | — |