Enterics for Global Health (EFGH)

NCT06047821 | Active Not Recruiting

• 1 other identifier: INV-01665
• Study Type: observational
• Target: 9,800
• Locations: 6 countries
• Sites: 29

Brief Summary

Diarrhea remains a leading cause of death among young children, with the majority of diarrhea deaths occurring in low- and middle-income countries. Childhood diarrhea caused by a type of bacteria called "Shigella" is responsible for an estimated 60,000 deaths each year and may cause particularly severe illness among children. Currently, there are several promising vaccines to prevent Shigella diarrhea in development, but key information is still needed to inform future vaccine studies. The purpose of this study, titled Enterics for Global Health (or the "EFGH"), is to determine the number and rate of new cases of Shigella diarrhea among children 6 to 35 months of age presenting to health facilities with diarrhea or dysentery. Over a two-year period, the EFGH study will enroll 1,400 children from each of the seven countries: Peru, Pakistan, Bangladesh, Mali, Malawi, Kenya, and The Gambia (9,800 children total).

Conditions

Shigella; Child; Diarrhea

Keywords

Epidemiology; Shigella; Diarrhea; Children; Enterics; Vaccine

Outcome Measures

Primary Outcomes (1)

• Shigella incidence

  The primary outcome measure is Shigella incidence, defined as incident diarrhea among children enrolled at health clinics attributable to Shigella by microbiological methods (culture or qPCR) divided by the estimated population living in the catchment area. Incidence will be reported as crude incidence as well as adjusted for healthcare seeking and the percentage of children who were enrolled.

  At enrollment in the study (cross-sectional)

Secondary Outcomes (7)

• Antimicrobial susceptibility

  At enrollment in the study (cross-sectional)

• Cost per episode treated

  3 months

• Death

  3 months

• Hospitalization

  3 months

• Persistent diarrhea (index episode)

  3 months

Study Arms (2)

Children with Shigella Diarrhea

Children with Shigella identified by culture or quantitative PCR

Children without Shigella Diarrhea

Children without Shigella identified by culture or quantitative PCR

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 6-35 months of age presenting with diarrhea at selected study health facilities in Bangladesh, Malawi, Kenya, Mali, the Gambia, Pakistan, and Peru.

You may qualify if:

• Child is 6-35 months of age
• Primary caregiver and child plan to remain at their current residence for at least the next 4 months
• Primary caregiver is able to provide informed consent (legal age or emancipated minor) and provides consent within a common language for which translations are available
• Child presents to health facility with diarrhea (≥3 abnormally loose or watery stools in the previous 24 hours) with or without the presence of blood
• Child resides within the pre-defined study area
• Fewer than 4 hours have passed since the child presented to a health facility
• Diarrhea episode is:
• Acute (onset within 7 days of study enrollment) and
• Represents a new episode (onset after at least 2 diarrhea-free days)
• Caregiver is willing to have child participate in follow-up visits at week 4 and month 3
• Willingness to have samples collected from the child (rectal swabs at enrollment)
• Site enrollment cap has not been met
• Child is not being referred to a non-EFGH facility at the time of screening

You may not qualify if:

• Child is \< 6-35 months of age
• Child is \> 6-35 months of age
• Primary caregiver and child do not plan to remain at their current residence for at least the next 4 months
• Primary caregiver is not able to provide informed consent (legal age or emancipated minor)
• Primary caregiver does not provide consent within a common language for which translations are available
• Child does not present to health facility with diarrhea (≥3 abnormally loose or watery stools in the previous 24 hours) with or without the presence of blood
• Child does not reside within the pre-defined study area
• or more hours have passed since the child presented to a health facility
• Diarrhea episode is not Acute (onset within 7 days of study enrollment)
• Diarrhea episode does not represent a new episode (onset after at least 2 diarrhea-free days)
• Caregiver is unwilling to have child participate in follow-up visits at week 4 and month 3
• Unwillingness to have samples collected from the child (rectal swabs at enrollment)
• Site enrollment cap has been met
• Child is being referred to a non-EFGH facility at the time of screening

Sponsors & Collaborators

• University of Washington: lead
• Aga Khan University: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• University of Maryland, Baltimore: collaborator
• University of Virginia: collaborator
• Asociacion Benefica Prisma: collaborator
• Medical Research Council Unit, The Gambia: collaborator
• Kenya Medical Research Institute: collaborator
• Center for Vaccine Development - Mali: collaborator
• Malawi-Liverpool-Wellcome Trust Clinical Research Programme: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (33)

Dhaka Medical College Hospital

Dhaka, Bangladesh

Location

EFGH Field Clinic

Dhaka, Bangladesh

Location

icddr,b Dhaka Hospital

Dhaka, Bangladesh

Location

Mugda Medical College Hospital

Dhaka, Bangladesh

Location

Sir Salimullah Medical College Hospital

Dhaka, Bangladesh

Location

Abidha Health Center

Siaya, Kenya

Location

Akala Health Center

Siaya, Kenya

Location

Bar Agulu Health Center

Siaya, Kenya

Location

Dienya Health Centre

Siaya, Kenya

Location

Lwak Mission Hospital

Siaya, Kenya

Location

Ongielo Health Centre

Siaya, Kenya

Location

Siaya County Referral Hospital

Siaya, Kenya

Location

Ting Wangi Health Center

Siaya, Kenya

Location

Wagai Health Center

Siaya, Kenya

Location

Ndirande Health Centre

Blantyre, Malawi

Location

Asacodjeneka Cscom

Bamako, Mali

Location

Asacodjip Cscom

Bamako, Mali

Location

Banconi CSCOM (ASACOBA)

Bamako, Mali

Location

CSREF Commune 1

Bamako, Mali

Location

Abbasi Shaheed Hospital

Karachi, Pakistan

Location

Ali Akbar Shah Center

Karachi, Pakistan

Location

Bhains colony AKU site

Karachi, Pakistan

Location

Khidmat e Alam Medical Centre

Karachi, Pakistan

Location

Sindh Government Hospital, Ibrahim Hyderi

Karachi, Pakistan

Location

Sindh Government Hospital, Korangi

Karachi, Pakistan

Location

America Health Post

Iquitos, Maynas, Peru

Location

Hospital de Apoloyo

Iquitos, Maynas, Peru

Location

Modelo Health Post

Iquitos, Maynas, Peru

Location

Progreso Health Post

Iquitos, Maynas, Peru

Location

San Juan Health Post

Iquitos, Maynas, Peru

Location

Santo Tomas Health Post

Iquitos, Maynas, Peru

Location

Basse Hospital

Basse Santa Su, Upper River Division, The Gambia

Location

Gambisara Health Centre (HC)

Basse Santa Su, Upper River Division, The Gambia

Location

Related Publications (6)

• Rogawski McQuade ET, Shaheen F, Kabir F, Rizvi A, Platts-Mills JA, Aziz F, Kalam A, Qureshi S, Elwood S, Liu J, Lima AAM, Kang G, Bessong P, Samie A, Haque R, Mduma ER, Kosek MN, Shrestha S, Leite JP, Bodhidatta L, Page N, Kiwelu I, Shakoor S, Turab A, Soofi SB, Ahmed T, Houpt ER, Bhutta Z, Iqbal NT. Epidemiology of Shigella infections and diarrhea in the first two years of life using culture-independent diagnostics in 8 low-resource settings. PLoS Negl Trop Dis. 2020 Aug 17;14(8):e0008536. doi: 10.1371/journal.pntd.0008536. eCollection 2020 Aug.

  PMID: 32804926 BACKGROUND

• Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, Wu Y, Sow SO, Sur D, Breiman RF, Faruque AS, Zaidi AK, Saha D, Alonso PL, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ochieng JB, Omore R, Oundo JO, Hossain A, Das SK, Ahmed S, Qureshi S, Quadri F, Adegbola RA, Antonio M, Hossain MJ, Akinsola A, Mandomando I, Nhampossa T, Acacio S, Biswas K, O'Reilly CE, Mintz ED, Berkeley LY, Muhsen K, Sommerfelt H, Robins-Browne RM, Levine MM. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet. 2013 Jul 20;382(9888):209-22. doi: 10.1016/S0140-6736(13)60844-2. Epub 2013 May 14.

  PMID: 23680352 BACKGROUND

• Liu J, Platts-Mills JA, Juma J, Kabir F, Nkeze J, Okoi C, Operario DJ, Uddin J, Ahmed S, Alonso PL, Antonio M, Becker SM, Blackwelder WC, Breiman RF, Faruque AS, Fields B, Gratz J, Haque R, Hossain A, Hossain MJ, Jarju S, Qamar F, Iqbal NT, Kwambana B, Mandomando I, McMurry TL, Ochieng C, Ochieng JB, Ochieng M, Onyango C, Panchalingam S, Kalam A, Aziz F, Qureshi S, Ramamurthy T, Roberts JH, Saha D, Sow SO, Stroup SE, Sur D, Tamboura B, Taniuchi M, Tennant SM, Toema D, Wu Y, Zaidi A, Nataro JP, Kotloff KL, Levine MM, Houpt ER. Use of quantitative molecular diagnostic methods to identify causes of diarrhoea in children: a reanalysis of the GEMS case-control study. Lancet. 2016 Sep 24;388(10051):1291-301. doi: 10.1016/S0140-6736(16)31529-X.

  PMID: 27673470 BACKGROUND

• Pavlinac PB, Rogawski McQuade ET, Platts-Mills JA, Kotloff KL, Deal C, Giersing BK, Isbrucker RA, Kang G, Ma LF, MacLennan CA, Patriarca P, Steele D, Vannice KS. Pivotal Shigella Vaccine Efficacy Trials-Study Design Considerations from a Shigella Vaccine Trial Design Working Group. Vaccines (Basel). 2022 Mar 22;10(4):489. doi: 10.3390/vaccines10040489.

  PMID: 35455238 BACKGROUND

• Kasumba IN, Badji H, Powell H, Hossain MJ, Omore R, Sow SO, Verani JR, Platts-Mills JA, Widdowson MA, Zaman SMA, Jones J, Sen S, Permala-Booth J, Nasrin S, Roose A, Nasrin D, Ochieng JB, Juma J, Doh S, Jones JCM, Antonio M, Awuor AO, Sugerman CE, Watson N, Focht C, Liu J, Houpt E, Kotloff KL, Tennant SM. Shigella in Africa: New Insights From the Vaccine Impact on Diarrhea in Africa (VIDA) Study. Clin Infect Dis. 2023 Apr 19;76(76 Suppl1):S66-S76. doi: 10.1093/cid/ciac969.

  PMID: 37074444 BACKGROUND

• von Seidlein L, Kim DR, Ali M, Lee H, Wang X, Thiem VD, Canh DG, Chaicumpa W, Agtini MD, Hossain A, Bhutta ZA, Mason C, Sethabutr O, Talukder K, Nair GB, Deen JL, Kotloff K, Clemens J. A multicentre study of Shigella diarrhoea in six Asian countries: disease burden, clinical manifestations, and microbiology. PLoS Med. 2006 Sep;3(9):e353. doi: 10.1371/journal.pmed.0030353.

  PMID: 16968124 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Shigella isolates, lactose fermenting sweep, and rectal swab/stool DNA; Specimens stored at -80 degrees Celsius at each respective country-site

MeSH Terms

Conditions

Dysentery, Bacillary; Diarrhea

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia B Pavlinac, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: August 25, 2022
• Primary Completion: August 17, 2024
• Study Completion: April 30, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

MA (1); PA (6); TH (2); BA (5); KE (9); PE (6)