NCT07106944

Brief Summary

In 2019, Indonesia's first WHO Tricycle Project revealed alarming rates of extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli across various sectors. The study found ESBL-producing E. coli in 40% of pregnant women, 57.7% of E. coli-induced bloodstream infections, 67.1% of broiler chicken, and 12.8% of total E. coli in water samples. In the first National Action Plan on Antimicrobial Resistance from Indonesia, the reduction of ESBL was identified as a clear goal. In E-Trike, Tricycle will be repeated, using the same methodology, to determine if a reduction has been achieved. Additionally, ESBL-positive Klebsiella pneumoniae will be included, as important pathogen for humans.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

August 11, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

July 3, 2025

Last Update Submit

August 4, 2025

Conditions

Carriage of ESBL-positive Escherichia ColiCarriage of ESBL-positive Klebsiella Pneumoniae

Keywords

ESBLcarriageEscherichia coliKlebsiella pneumoniaeOne Health

Outcome Measures

Primary Outcomes (4)

  • Number of pregnant women in the community in Jakarta that carry ESBL-positive E. coli / Klebsiella pneumoniae in their rectum or throat

    July 2025-March 2026

  • Number of ESBL-positive E. coli/K. pneumoniae among all blood cultures taken / all E. coli/K. pneumoniae from blood cultures

    July 2025 - March 2026

  • Prevalence of ESBL-Ec and ESBL-Kp in the food chain (chicken) in Jakarta, Indonesia

    July 2025 - March 2026

  • Prevalence of ESBL-Ec and ESBL-Kp in the environment (water) in Jakarta, Indonesia

    July 2025 - March 2026

Secondary Outcomes (3)

  • Number of ESBL-Ec and ESBL-Kp ("yield") found using the ESBL Chromagar™ plate compared to the MacConkey agar plate supplemented with 4 mg/L cefotaxime per human subject or chicken or environmental sample included.

    July 2025-March 2026

  • Number of ESBL-Ec and ESBL-Kp found in the study with resistance to carbapenem antibiotics and other relevant classes of antibiotic.

    July 2025 - March 2026

  • The prevalence of ESBL resistant genes among the ESBL-Ec and ESBL-Kp isolates found in the study based on genomic analysis.

    July 2025-March 2026

Study Arms (1)

Community pregnant women

Pregnant women who do antenatal visits in primary health care centre (Puskesmas) located around Cipto Mangunkusumo Hospital, Persahabatan Hospital and Sulianti Saroso Hospital; Puskesmas Johar Baru, Puskesmas Pulogadung, and Puskesmas Koja. After informed consent, a rectal swab and throat swab will be taken. Basic demographic data will be recorded.

Other: Community pregnant women: rectal and throat swab

Interventions

Community pregnant women: rectal and throat swabOTHER

Community pregnant women: rectal and throat swab

Community pregnant women

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women at antenatal visits in 3 puskesmas (public health centers)

You may qualify if:

  • pregnant women at antenatal visits

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Puspandari N, Sunarno S, Febrianti T, Febriyana D, Saraswati RD, Rooslamiati I, Amalia N, Nursofiah S, Hartoyo Y, Herna H, Mursinah M, Muna F, Aini N, Risniati Y, Dhewantara PW, Allamanda P, Wicaksana DN, Sukoco R, Efadeswarni, Nelwan EJ, Cahyarini, Haryanto B, Sihombing B, Soares Magalhaes RJ, Kakkar M, Setiawaty V, Matheu J. Extended spectrum beta-lactamase-producing Escherichia coli surveillance in the human, food chain, and environment sectors: Tricycle project (pilot) in Indonesia. One Health. 2021 Sep 23;13:100331. doi: 10.1016/j.onehlt.2021.100331. eCollection 2021 Dec.

    PMID: 34632041BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacterial isolates

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Juliëtte A. Severin, MD PhD

CONTACT

0031-(0)10-7033510fleming.fellowship@erasmusmc.nl; j.severin@erasmusmc.nl

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD PhD

Study Record Dates

First Submitted

July 3, 2025

First Posted

August 6, 2025

Study Start

August 11, 2025

Primary Completion

March 30, 2026

Study Completion

April 30, 2026

Last Updated

August 6, 2025

Record last verified: 2025-07