NCT03722615 is a clinical trial in Cytomegalovirus Congenital, sponsored by University of Witwatersrand, South Africa.

Who is sponsoring NCT03722615?

NCT03722615 is sponsored by University of Witwatersrand, South Africa.

What condition does NCT03722615 study?

NCT03722615 studies Cytomegalovirus Congenital, Hearing Loss, Neurodevelopmental Disorders, Immunogenicity, Neonatal Death, Stillbirth.

Is NCT03722615 still recruiting?

NCT03722615 is currently completed. Last updated 6 August 2019.

Last reviewed 2019-08-06 · How we verify

NCT03722615

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa

Completed Last updated 6 August 2019

What this trial tests

trial in Cytomegalovirus Congenital in 3,000 participants. Completed in 1 April 2019.

Timeline

6 May 2016

Primary endpoint
1 April 2019

1 April 2019

Quick facts

Lead sponsor	University of Witwatersrand, South Africa
Status	Completed
Study type	OBSERVATIONAL
Enrollment	3,000
Start date	6 May 2016
Primary completion	1 April 2019
Estimated completion	1 April 2019
Sites	1 location across South Africa

Conditions studied

Cytomegalovirus Congenital — all drugs for Cytomegalovirus Congenital →
Hearing Loss — all drugs for Hearing Loss →
Neurodevelopmental Disorders — all drugs for Neurodevelopmental Disorders →
Immunogenicity — all drugs for Immunogenicity →

Sponsor

University of Witwatersrand, South Africa

Who can join

Adults 1 Minute to 48 Hours, any sex, with Cytomegalovirus Congenital or Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this project is to determine the epidemiology of congenital cytomegalovirus (CMV) infection and incidence of subsequent permanent neurological sequelae in a high HIV prevalent setting in Soweto, Johannesburg. A cross-sectional study will be conducted on mother-infant pairs, screening mothers for CMV infection and newborns for congenital CMV infection. Maternal CMV prevalence will be determined by testing for CMV specific antibodies in blood. Newborn congenital infection will be determined by polymerase chain reaction (PCR) tests on newborn saliva and urine within 3 weeks of birth. Various risk factors associated with congenital CMV such as HIV exposure, and gestational age will be assessed. The association between maternal vaginal CMV shedding postnatally with congenital CMV infection will be explored by swabbing maternal vaginal fluid and conducting quantitative CMV PCR analysis. Newborns confirmed with congenital CMV and a control group of uninfected newborns will form a cohort to be followed up until 12 months of age monitoring for various neurological sequelae such as hearing loss, neurodevelopmental impairment, ocular damage, cerebral damage and seizures. A comparison of vaccine immune responses between cases of congenital CMV and the CMV uninfected infants to the primary series of vaccines in the National Expanded Programme on Immunisation will be compared. The contribution of CMV infection to neonatal death and stillbirths will be described by minimally invasive tissue sampling (MITS) for CMV on babies that die during the neonatal period and stillbirths.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Neurological and growth outcomes in South African children with congenital cytomegalovirus: A cohort study.
Pathirana J, Texeira L, Munian H, Nakwa F, et al · · 2020 · cited 7× · PMID 32941484 · DOI 10.1371/journal.pone.0238102

Verify or expand the search:

Other University of Witwatersrand, South Africa trials

Trials by the same sponsor.

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NCT05846503 — iHEART-SA Intervention Study · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03722615 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Witwatersrand, South Africa
Last refreshed: 6 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03722615.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing