ShigellaEFGHNCT06047821
Enterics for Global Health (EFGH)
An observational study of Shigella and Child, run by University of Washington at 33 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 35 months
- How many people
- 9,800 participants
- Where
- 33 sitesin 7 countries
- Study dates
- 25 Aug 2022to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 35 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- Child does not reside within the pre-defined study area
- 4 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
Trial locations and contacts
33 sites in 7 countries.
33 sites in 7 countries
Kenya9 sites
Abidha Health Center
Siaya
Akala Health Center
Siaya
Bar Agulu Health Center
Siaya
Dienya Health Centre
Siaya
Lwak Mission Hospital
Siaya
Ongielo Health Centre
Siaya
Siaya County Referral Hospital
Siaya
Ting Wangi Health Center
Siaya
Wagai Health Center
Siaya
Pakistan6 sites
Abbasi Shaheed Hospital
Karachi
Ali Akbar Shah Center
Karachi
Bhains colony AKU site
Karachi
Khidmat e Alam Medical Centre
Karachi
Sindh Government Hospital, Ibrahim Hyderi
Karachi
Sindh Government Hospital, Korangi
Karachi
Peru6 sites
America Health Post
Iquitos, Maynas
Hospital de Apoloyo
Iquitos, Maynas
Modelo Health Post
Iquitos, Maynas
Progreso Health Post
Iquitos, Maynas
San Juan Health Post
Iquitos, Maynas
Santo Tomas Health Post
Iquitos, Maynas
Bangladesh5 sites
Dhaka Medical College Hospital
Dhaka
EFGH Field Clinic
Dhaka
icddr,b Dhaka Hospital
Dhaka
Mugda Medical College Hospital
Dhaka
Sir Salimullah Medical College Hospital
Dhaka
Mali4 sites
Asacodjeneka Cscom
Bamako
Asacodjip Cscom
Bamako
Banconi CSCOM (ASACOBA)
Bamako
CSREF Commune 1
Bamako
The Gambia2 sites
Basse Hospital
Basse Santa Su, Upper River Division
Gambisara Health Centre (HC)
Basse Santa Su, Upper River Division
About this study
Official title: The Incidence and Burden of Shigella Diarrhea in Children Aged 6-35 Months: the Enterics for Global Health (EFGH) - Shigella Burden Study
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).
Read the detailed description
In low- and middle-income countries, nearly one third of children experience at least one episode of Shigella-attributable diarrhea during their first 2 years of life. In addition to it being a leading cause of diarrhea, this enteric bacterium is also associated with linear growth faltering, a precursor to stunting. Stunting is a marker of vulnerability to childhood infection, decreased vaccine efficacy and lifelong morbidity. Currently, several promising Shigella vaccines are in development. Eventual Phase 2b/3 Shigella vaccine trials will require a consortium of potential vaccine trial sites in settings with a high incidence of Shigella-attributed medically-attended diarrhea, high participant retention, and the laboratory capacity to confirm Shigella infection. The Enterics for Global Health (EFGH) Shigella burden study will employ cross-sectional and longitudinal study designs to establish updated incidence rates and document consequences of Shigella diarrhea within 7 country sites in Africa, Asia, and Latin America. Over a two-year period, the EFGH study will enroll 9,800 children (1,400 per country site) between 6-35 months with medically-attended diarrhea. Through this multi-country surveillance network, selected EFGH sites will be ready to quickly implement rigorous and efficient vaccine trials and provide critical data to policy makers about the relative importance of this vaccine-preventable disease, accelerating the time to vaccine availability and uptake among children in high Shigella burden settings.
Primary Aims
- Determine the incidence of Shigella-attributed medically-attended diarrhea in children 6 to 35 months of age in each of the EFGH country sites.
Secondary Aims
- Determine the incidence of Shigella medically-attended diarrhea by serotype, severity definition, laboratory method (culture vs. qPCR), age, and by season.
- Describe the prevalence of resistance to commonly used antibiotics in Shigella isolates in each EFGH country site.
- Determine the risk of death, hospitalization, persistent diarrhea, diarrhea recurrence, and linear growth faltering in the 3 months following an episode of Shigella medically-attended diarrhea.
- Compare various severity definitions in their ability to distinguish Shigella from non-Shigella attributable diarrhea and ability to predict risk of death or hospitalization in the subsequent 3 months.
- Quantify the cost incurred by families and health care systems due to Shigella morbidity and mortality.
- Identify optimal laboratory methods for Shigella culture by:
- comparing the isolation rate of Shigella between two transport media for rectal swabs (Cary-Blair and modified Buffered Glycerol Saline [BGS])
- comparing the isolation rate of Shigella between two fecal sample types (rectal swabs and whole stool) among the subset of children who produced whole stool in The Gambia and Bangladesh country sites.
- Keywords
- Epidemiology, Shigella, Diarrhea, Children, Enterics, Vaccine
- Medical subject headings
- Dysentery, Bacillary, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment in the study (cross-sectional)
Secondary outcomes (7)
Antimicrobial susceptibility
Antimicrobial susceptibility will be computed separately for Ampicillin, Azithromycin, Ceftriaxone, Ciprofloxacin, Nalidixic Acid, Pivmecillinam, and Trimethoprim-Sulfamethoxazole and defined as intermediate or resistant according to the most recent Clinical and Laboratory Standards Institute (CLSI) interpretive standards at the time of data analysis.
Measured: At enrollment in the study (cross-sectional)
Cost per episode treated
Cost per episode treated will be calculated using the direct and indirect financial costs and total economic costs of illness per outpatient and inpatient episode of Shigella-associated diarrhea from the household and, separately, payer perspectives.
Measured: 3 months
Death
Death: all cause mortality during follow-up among enrolled children.
Measured: 3 months
Hospitalization
Hospitalization will be defined as an overnight stay (child was on the ward from at least 12am to 6am) that occurs during follow-up among enrolled children
Measured: 3 months
Persistent diarrhea (index episode)
Persistent diarrhea will be defined as 14 or more days of diarrhea (starting from the date at which the diarrhea first started (as opposed to date at presentation to an EFGH facility) and concluding at the last day of diarrhea prior to the two consecutive diarrhea-free days concluding the episode.
Measured: 3 months
Diarrhea/dysentery recurrence
Diarrhea/dysentery recurrence will be defined as new diarrhea/dysentery episodes (>48 hours after a diarrhea-free period).
Measured: 3 months
Change in linear growth
Change in mean length/height-for-age z-score (∆LAZ/∆HAZ) from enrollment to 3 months. The 2006 World Health Organization (WHO) reference population will be used to calculate HAZ from the average of two repeated length/height (cm) measures per child per time point
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start25 Aug 2022
- Primary completion17 Aug 2024
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ShigellaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, International Centre for Diarrhoeal Disease Research, Bangladesh, University of Maryland, Baltimore, University of Virginia, Asociacion Benefica Prisma, Medical Research Council Unit, The Gambia, Kenya Medical Research Institute, Center for Vaccine Development - Mali, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Patricia B Pavlinac, University of Washington
- Investigators
- Patricia B Pavlinac, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047821
- Sponsor's protocol ID
- INV-01665
- Acronym
- EFGH
- Status last verified
- Jan 2025
- First submitted
- 12 Sep 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The publicly available analytic de-identified datasets corresponding to each specific aim, along with corresponding analytic code in Stata or R, will be posted to Dataverse, which is a publicly available data repository. Data requests for data not included in the publicly available analytic datasets corresponding to each aim will be managed by the University of Washington and relevant EFGH site investigators.
Publications
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.
PubMed 32804926Kotloff 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.
PubMed 23680352Liu 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.
PubMed 27673470Pavlinac 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.
PubMed 35455238Kasumba 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.
PubMed 37074444von 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.
PubMed 16968124Bhuiyan MTR, Liu J, Juma J, Horne B, Hotwani A, Badji H, Maiden VA, Ochieng JB, Romaina-Cachique LA, Aluoch LR, Ambila LA, Aziz F, Charles M, Feutz EL, Garcia Bardales PF, Hossain MJ, Iqbal J, Islam MT, Jabang A, Jarju S, Jere KC, Kabir F, Kawonga F, Keita AM, Khanam F, Manzanares Villanueva K, Mosharraf MP, Omore R, Paredes Olortegui M, Pavlinac PB, Platts-Mills JA, McQuade ETR, Saidi Q, Sears KT, Tapia MD, Traore A, Qadri F, Penataro Yori P, Qamar FN, Sow SO, Kotloff KL, Tennant SM, Houpt ER, Cornick J, Secka O; EFGH Consortium. Optimizing Shigella isolation: a multi-site evaluation of laboratory culture methods for Shigella detection, speciation, and serotyping with different transport media and sample types in the Enterics for Global Health study. J Clin Microbiol. 2026 Apr 8;64(4):e0127925. doi: 10.1128/jcm.01279-25. Epub 2026 Feb 26.
PubMed 41746130
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Burden of Shigella Diarrhea in Children Aged 6-35 Months: the Enterics for Global Health (EFGH) - Shigella Burden Study
- ClinicalTrials.gov ID
- NCT06047821
- Acronym / sponsor ID
- EFGH / INV-01665
- Keywords
- Epidemiology, Shigella, Diarrhea, Children, Enterics, Vaccine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,800 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Aga Khan University, International Centre for Diarrhoeal Disease Research, Bangladesh, University of Maryland, Baltimore, University of Virginia, Asociacion Benefica Prisma, Medical Research Council Unit, The Gambia, Kenya Medical Research Institute, Center for Vaccine Development - Mali, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Bill and Melinda Gates Foundation
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 17 Aug 2024 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
In low- and middle-income countries, nearly one third of children experience at least one episode of Shigella-attributable diarrhea during their first 2 years of life. In addition to it being a leading cause of diarrhea, this enteric bacterium is also associated with linear growth faltering, a precursor to stunting. Stunting is a marker of vulnerability to childhood infection, decreased vaccine efficacy and lifelong morbidity. Currently, several promising Shigella vaccines are in development. Eventual Phase 2b/3 Shigella vaccine trials will require a consortium of potential vaccine trial sites in settings with a high incidence of Shigella-attributed medically-attended diarrhea, high participant retention, and the laboratory capacity to confirm Shigella infection. The Enterics for Global Health (EFGH) Shigella burden study will employ cross-sectional and longitudinal study designs to establish updated incidence rates and document consequences of Shigella diarrhea within 7 country sites in Africa, Asia, and Latin America. Over a two-year period, the EFGH study will enroll 9,800 children (1,400 per country site) between 6-35 months with medically-attended diarrhea. Through this multi-country surveillance network, selected EFGH sites will be ready to quickly implement rigorous and efficient vaccine trials and provide critical data to policy makers about the relative importance of this vaccine-preventable disease, accelerating the time to vaccine availability and uptake among children in high Shigella burden settings.
Primary Aims
- Determine the incidence of Shigella-attributed medically-attended diarrhea in children 6 to 35 months of age in each of the EFGH country sites.
Secondary Aims
- Determine the incidence of Shigella medically-attended diarrhea by serotype, severity definition, laboratory method (culture vs. qPCR), age, and by season.
- Describe the prevalence of resistance to commonly used antibiotics in Shigella isolates in each EFGH country site.
- Determine the risk of death, hospitalization, persistent diarrhea, diarrhea recurrence, and linear growth faltering in the 3 months following an episode of Shigella medically-attended diarrhea.
- Compare various severity definitions in their ability to distinguish Shigella from non-Shigella attributable diarrhea and ability to predict risk of death or hospitalization in the subsequent 3 months.
- Quantify the cost incurred by families and health care systems due to Shigella morbidity and mortality.
- Identify optimal laboratory methods for Shigella culture by:
- comparing the isolation rate of Shigella between two transport media for rectal swabs (Cary-Blair and modified Buffered Glycerol Saline [BGS])
- comparing the isolation rate of Shigella between two fecal sample types (rectal swabs and whole stool) among the subset of children who produced whole stool in The Gambia and Bangladesh country sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Shigella incidence
Time frame: At enrollment in the study (cross-sectional)
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.
7 secondary outcomes
Antimicrobial susceptibility
Time frame: At enrollment in the study (cross-sectional)
Cost per episode treated
Time frame: 3 months
Death
Time frame: 3 months
Hospitalization
Time frame: 3 months
Persistent diarrhea (index episode)
Time frame: 3 months
Diarrhea/dysentery recurrence
Time frame: 3 months
Change in linear growth
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Background: PubMed 32804926Rogawski 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.
- Background: PubMed 23680352Kotloff 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.
- Background: PubMed 27673470Liu 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.
- Background: PubMed 35455238Pavlinac 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.
- Background: PubMed 37074444Kasumba 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.
- Background: PubMed 16968124von 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.
- Derived from this study: PubMed 41746130Bhuiyan MTR, Liu J, Juma J, Horne B, Hotwani A, Badji H, Maiden VA, Ochieng JB, Romaina-Cachique LA, Aluoch LR, Ambila LA, Aziz F, Charles M, Feutz EL, Garcia Bardales PF, Hossain MJ, Iqbal J, Islam MT, Jabang A, Jarju S, Jere KC, Kabir F, Kawonga F, Keita AM, Khanam F, Manzanares Villanueva K, Mosharraf MP, Omore R, Paredes Olortegui M, Pavlinac PB, Platts-Mills JA, McQuade ETR, Saidi Q, Sears KT, Tapia MD, Traore A, Qadri F, Penataro Yori P, Qamar FN, Sow SO, Kotloff KL, Tennant SM, Houpt ER, Cornick J, Secka O; EFGH Consortium. Optimizing Shigella isolation: a multi-site evaluation of laboratory culture methods for Shigella detection, speciation, and serotyping with different transport media and sample types in the Enterics for Global Health study. J Clin Microbiol. 2026 Apr 8;64(4):e0127925. doi: 10.1128/jcm.01279-25. Epub 2026 Feb 26.
- Individual participant dataSharing planned: Yes. The publicly available analytic de-identified datasets corresponding to each specific aim, along with corresponding analytic code in Stata or R, will be posted to Dataverse, which is a publicly available data repository. Data requests for data not included in the publicly available analytic datasets corresponding to each aim will be managed by the University of Washington and relevant EFGH site investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia B Pavlinac, PhD principal investigator
University of Washington
33 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shigella and Child, run by University of Washington at 33 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Kenya, Pakistan, Peru, Bangladesh, Mali and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shigella incidence (time frame: At enrollment in the study (cross-sectional)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06047821, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.