Trial Evaluating Ambulatory Therapy of Travelers’ Diarrhea (TrEAT TD) Study: A Randomized Controlled Trial Comparing 3 Single-Dose Antibiotic Regimens With Loperamide

Ms, Riddle; Connor, Patrick; Fraser, Jamie; Ck, Porter; Swierczewski, Brett E.; Ej, Hutley; Danboise, Brook; Mp, Simons; Hulseberg, Christine E.; Lalani, Tahaniyat; Rl, Gutierrez; Dr, Tribble

doi:10.1093/cid/cix693

Cited by 48 publications

(32 citation statements)

References 34 publications

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“…The study design and results of the clinical trial have been previously reported [ 11 ]. The study was approved by the Uniformed Services University Infectious Disease Institutional Review Board, United Kingdom Ministry of Defence Research Ethics Committee, and the Kenya Medical Research Institute Ethical Review Committee.…”

Section: Methodsmentioning

confidence: 99%

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Comparison of stool collection and storage on Whatman FTA Elute cards versus frozen stool for enteropathogen detection using the TaqMan Array Card PCR assay

et al. 2018

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The use of Polymerase Chain Reaction (PCR) assays for pathogen detection in travelers’ diarrhea (TD) field studies is limited by the on-site processing and storage requirements for fecal specimens. The objectives of this investigation were to i) characterize the pathogen distribution in deployed military personnel with TD using the TaqMan® Array Card PCR (TAC) on frozen stool and diarrheal smears on Whatman FTA Elute cards (FTA cards), and to ii) compare TAC detection of enteropathogen targets using smeared FTA cards and frozen stool, using TAC on frozen stool as the ‘reference standard’. Stool samples, obtained from active duty personnel with acute TD enrolled in a field trial, were smeared onto FTA cards and stored at room temperature. A corresponding aliquot of stool was frozen in a cryovial. FTA cards and frozen stool samples were tested at a central lab, using a customized TAC for detection of TD pathogens. 187 paired frozen stool samples and smeared FTA cards were stored for a median of 712 days (IQR 396–750) before testing. Overall detection rates were 78.6% for frozen stool and 73.2% for FTA cards. Diarrheagenic Escherichia coli were the most common bacteria identified. Using the TAC results on frozen stool as the reference, the overall sensitivity and specificity of TAC on FTA cards was 72.9% and 98.0% respectively. TAC on FTA cards demonstrated a decrease in sensitivity with increasing frozen stool quantification cycle (Cq) (90.0% in FTA cards with a corresponding frozen stool Cq < 30, and 72.9% in samples with a corresponding frozen stool Cq < 35). Our findings support the use and further development of FTA cards in combination with a quantitative PCR assay for enteropathogen detection in TD field studies.

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Section: Methodsmentioning

confidence: 99%

“…The Trial Evaluating Ambulatory Therapy for TD (TrEAT TD) study evaluated the effectiveness of single dose antibiotic therapy for treatment of ambulatory TD in deployed UK and US military personnel [ 11 ]. Subjects provided a stool sample prior to therapy, a portion of which was smeared onto a FTA card and another frozen in a cryovial.…”

Section: Introductionmentioning

confidence: 99%

Comparison of stool collection and storage on Whatman FTA Elute cards versus frozen stool for enteropathogen detection using the TaqMan Array Card PCR assay

et al. 2018

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“…103 In this study, U.S. and U.K. adults with acute non-inflammatory diarrhea at four military deployment sites in Afghanistan, Djibouti, Kenya, and Honduras were randomized and received single-dose levofloxacin (500 mg; 111 persons), azithromycin (500 mg; 106 persons), and rifaximin (1650 mg, 107 persons) plus loperamide (labelled dosing). The primary outcome of clinical cure was evaluated in a non-inferiority trial design with azithromycin and rifaximin versus a levofloxacin standard.…”

Section: Methodsmentioning

confidence: 99%

Management of Acute Diarrheal Illness During Deployment: A Deployment Health Guideline and Expert Panel Report

et al. 2017

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Background Acute diarrheal illness during deployment causes significant morbidity and loss of duty days. Effective and timely treatment is needed to reduce individual, unit, and health system performance impacts. Methods This critical appraisal of the literature, as part of the development of expert consensus guidelines, asked several key questions related to self-care and healthcare-seeking behavior, antibiotics for self-treatment of travelers’ diarrhea, what antibiotics/regimens should be considered for treatment of acute watery diarrhea and febrile diarrhea and/or dysentery, and when and what laboratory diagnostics should be used to support management of deployment-related travelers’ diarrhea. Studies of acute diarrhea management in military and other travelers were assessed for relevance and quality. Based on this critical appraisal, guideline recommendations were developed and graded by the Expert Panel using good standards in clinical guideline development methodology. Results New definitions for defining the severity of diarrhea during deployment were established. A total of 13 graded recommendations on the topics of prophylaxis, therapy and diagnosis, and follow-up were developed. In addition, four non-graded consensus-based statements were adopted. Conclusions Successful management of acute diarrheal illness during deployment requires action at the provider, population, and commander levels. Strong evidence supports that single-dose antimicrobial therapy is effective in most cases of moderate to severe acute diarrheal illness during deployment. Further studies are needed to address gaps in available knowledge regarding optimal therapies for treatment, prevention, and laboratory testing of acute diarrheal illness.

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“…In this investigation, we characterized a collection of EAEC strains isolated from DMP enrolled in the Trial Evaluating Ambulatory Therapy of Travelers' Diarrhea (TrEAT TD) Study (Riddle et al, 2017) by whole genome sequencing and analysis, biofilm formation, adherence to HEp-2 cells, and, for a subset, the capacity to cause failure-to-thrive (FTT) in an Amp-treated mouse model with the goal of identifying a genotype more associated with TD in the DMP population.…”

Section: Introductionmentioning

confidence: 99%

Genetic and Virulence Profiles of Enteroaggregative Escherichia coli (EAEC) Isolated From Deployed Military Personnel (DMP) With Travelers' Diarrhea

Petro

Duncan

Seldina

et al. 2020

Front. Cell. Infect. Microbiol.

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To discern if there was a particular genotype associated with clinical enteroaggregative Escherichia coli (EAEC) strains isolated from deployed military personnel (DMP) with travelers' diarrhea (TD), we characterized a collection of EAEC from DMP deployed to Afghanistan, Djibouti, Kenya, or Honduras. Although we did not identify a specific EAEC genotype associated with TD in DMP, we found that EAEC isolated at the first clinic visit were more likely to encode the dispersin gene aap than EAEC collected at follow-up visits. A majority of the EAEC isolates were typical EAEC that adhered to HEp-2 cells, formed biofilms, and harbored genes for aggregative adherence fimbriae (AAF), AggR, and serine protease autotransporters of Enterobacteriaceae (SPATEs). A separate subset of the EAEC had aggR and genes for SPATEs but encoded a gene highly homologous to that for CS22, a fimbriae more commonly found in enterotoxigenic E. coli. None of these CS22-encoding EAEC formed biofilms in vitro or adhered to HEp-2 cells. Whole genome sequence and single nucleotide polymorphism analyses demonstrated that most of the strains were genetically diverse, but that a few were closely related. Isolation of these related strains occurred within days to more than a year apart, a finding that suggests a persistent source and genomic stability. In an ampicillin-treated mouse model we found that an agg4A+ aar-isolate formed a biofilm in the intestine and caused reduced weight gain in mice, whereas a strain that did not form an in vivo biofilm caused no morbidity. Our diverse strain collection from DMP displays the heterogeneity of EAEC strains isolated from human patients, and our mouse model of infection indicated the genotype agg4A+ aar-and/or capacity to form biofilm in vivo may correlate to disease severity.

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Trial Evaluating Ambulatory Therapy of Travelers’ Diarrhea (TrEAT TD) Study: A Randomized Controlled Trial Comparing 3 Single-Dose Antibiotic Regimens With Loperamide

Abstract: NCT01618591.

Cited by 48 publications

References 34 publications

Comparison of stool collection and storage on Whatman FTA Elute cards versus frozen stool for enteropathogen detection using the TaqMan Array Card PCR assay

Comparison of stool collection and storage on Whatman FTA Elute cards versus frozen stool for enteropathogen detection using the TaqMan Array Card PCR assay

Management of Acute Diarrheal Illness During Deployment: A Deployment Health Guideline and Expert Panel Report

Genetic and Virulence Profiles of Enteroaggregative Escherichia coli (EAEC) Isolated From Deployed Military Personnel (DMP) With Travelers' Diarrhea

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