Drug Resistance, MicrobialLWAPANCT06617260
Longitudinal FolloW-up of Antimicrobial Resistance From Perinatal Acquisition (LWAPA): A SHARE Study ASSESSING AND PREVENTING Antimicrobial Resistance in the Perinatal Period
An observational study of Drug Resistance, Microbial, run by University of Pennsylvania at 1 site in Botswana.
Trial summary
In 2022, in collaboration between the Botswana Ministry of Health (MOH), the U.S. Centers for Disease Control \& Prevention, and the Botswana-UPenn Partnership (BUP), a program was launched called, "Surveillance of Healthcare-associated infections \& Antimicrobial Resistance", or "SHARE". Read more about this study
- Who is it for?
- Ages 36 weeks and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Resistance, Microbial
- How many people
- 1,000 participants
- Where
- 1 siteBotswana
- Study dates
- 15 Feb 2024to 28 Feb 2027
- How long will I take part?
- 1 Year
- 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 36 weeks and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with: * Pre-term labor (24-36 weeks gestation) * Pre-eclampsia * Post-dates (\>41 weeks gestation) The rationale for recruiting these mothers is that there is a high probability of having a baby who will ultimately be admitted to the NNU
Who may be able to join
- Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with:
- Pre-term labor (24-36 weeks gestation)
- Pre-eclampsia
- Post-dates (\>41 weeks gestation)-
Who cannot join
- Mothers/babies who have been admitted for more than 96 hours will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
In 2022, in collaboration between the Botswana Ministry of Health (MOH), the U.S. Centers for Disease Control \& Prevention, and the Botswana-UPenn Partnership (BUP), a program was launched called, "Surveillance of Healthcare-associated infections \& Antimicrobial Resistance", or "SHARE". The aims of SHARE are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs, leveraging data to prevent, detect, and contain emerging AMR threats; 3) deploy study teams to answer critical public health surveillance questions, and 4) to build a national network of hospital infection prevention and control (IPC) resources to prevent, detect, and contain emerging infectious disease threats.
Read the detailed description
The Longitudinal FolloW-up of Antimicrobial Resistance from Perinatal Acquisition (LWAPA) study will assess the extent of perinatally-acquired MDROs and GBS, exploring factors influencing both maternal and neonatal colonization and better understanding the long-term outcomes in families affected by MDRO colonization.
By collecting samples at critical time points (e.g. during labour, after delivery, sequentially in the hospital, and then 3, 6, 9, and 12 months of age, the LWAPA study aims to identify modifiable factors influencing colonization risk. The results from this study can help inform and operationalize infection prevention measures which are poised to reduce the incidence of healthcare-associated infections and other poor health outcomes.
In Setswana, 'lwapa' means 'home' or 'family', which captures how this study aims to understand healthcare-associated AMR is impacting households and communities.
- Conditions
- Drug Resistance, Microbial
- Keywords
- Antimicrobial
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 |
|---|---|---|
| Neonates and mothers | Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with: * Pre-term labor (24-36 weeks gestation) * Pre-eclampsia * Post-dates (>41 weeks gestation) The rationale for recruiting these mothers is that there is a high probability of having a baby who will ultimately be admitted to the NNU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal FolloW-up of Antimicrobial Resistance from Perinatal Acquisition
Ultimately, the goal of the LWAPA study is to better understand perinatal transmission of AMR in order to inform prevention measures
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start15 Feb 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistance, MicrobialStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebbing Lautenbach, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617260
- Sponsor's protocol ID
- 855283
- Other IDs
- Antimicrobial resistance(AMR),
- Acronym
- LWAPA
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal FolloW-up of Antimicrobial Resistance From Perinatal Acquisition (LWAPA): A SHARE Study ASSESSING AND PREVENTING Antimicrobial Resistance in the Perinatal Period
- ClinicalTrials.gov ID
- NCT06617260
- Acronym / sponsor ID
- LWAPA / 855283
- Conditions
- Drug Resistance, Microbial
- Keywords
- Antimicrobial
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 27 Sep 2024 (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.
In 2022, in collaboration between the Botswana Ministry of Health (MOH), the U.S. Centers for Disease Control \& Prevention, and the Botswana-UPenn Partnership (BUP), a program was launched called, "Surveillance of Healthcare-associated infections \& Antimicrobial Resistance", or "SHARE". The aims of SHARE are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs, leveraging data to prevent, detect, and contain emerging AMR threats; 3) deploy study teams to answer critical public health surveillance questions, and 4) to build a national network of hospital infection prevention and control (IPC) resources to prevent, detect, and contain emerging infectious disease threats.
Detailed description
The Longitudinal FolloW-up of Antimicrobial Resistance from Perinatal Acquisition (LWAPA) study will assess the extent of perinatally-acquired MDROs and GBS, exploring factors influencing both maternal and neonatal colonization and better understanding the long-term outcomes in families affected by MDRO colonization.
By collecting samples at critical time points (e.g. during labour, after delivery, sequentially in the hospital, and then 3, 6, 9, and 12 months of age, the LWAPA study aims to identify modifiable factors influencing colonization risk. The results from this study can help inform and operationalize infection prevention measures which are poised to reduce the incidence of healthcare-associated infections and other poor health outcomes.
In Setswana, 'lwapa' means 'home' or 'family', which captures how this study aims to understand healthcare-associated AMR is impacting households and communities.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates and mothers | – | –Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with: * Pre-term labor (24-36 weeks gestation) * Pre-eclampsia * Post-dates (>41 weeks gestation) The rationale for recruiting these mothers is that there is a high probability of having a baby who will ultimately be admitted to the NNU |
Who may qualify
- Ages
- 36 weeks and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with: * Pre-term labor (24-36 weeks gestation) * Pre-eclampsia * Post-dates (\>41 weeks gestation) The rationale for recruiting these mothers is that there is a high probability of having a baby who will ultimately be admitted to the NNU
Key inclusion criteria (4 listed)
- Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with:
- Pre-term labor (24-36 weeks gestation)
- Pre-eclampsia
- Post-dates (\>41 weeks gestation)-
Key exclusion criteria (1 listed)
- Mothers/babies who have been admitted for more than 96 hours will be excluded
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
Longitudinal FolloW-up of Antimicrobial Resistance from Perinatal Acquisition
Time frame: 12 months
Ultimately, the goal of the LWAPA study is to better understand perinatal transmission of AMR in order to inform prevention measures
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 19 Nov 2025.
Related trials for Drug Resistance, Microbial
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
RecruitingPhase 1
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers
Infectious Diseases, Antimicrobial Drug Resistance
Active, not recruitingObservational study
Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
Latent Tuberculosis, Staphylococcus Aureus
RecruitingObservational study
Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris
Candida Auris Infection, Candida Auris Colonization
RecruitingObservational study
Impacts of HIV Treatment Regimens on Archived Drug Resistance
HIV -1 Infection, Antiretroviral Therapy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Resistance, Microbial, run by University of Pennsylvania at 1 site in Botswana.
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 4 inclusion and 1 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 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. 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?
Longitudinal FolloW-up of Antimicrobial Resistance from Perinatal Acquisition (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025.