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ERASE - Impact of COVID-19 on Malaria Control

NCT05348746 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-04-27

No results posted yet for this study

Summary

Objective: Measure incidence of malaria and malaria-related outcomes, evaluating potential impact of the SARS-CoV2 epidemic and of antimalarial resistance in Oyam and Kole district, Uganda with focus on pregnant women.

Study design: Facility-based, prospective, observational study.

Study population: All pregnant women at any gestational age presenting to the Aber Hospitals during the study period both at the emergency department or the Ante-Natal Care (ANC) clinic will be eligible to participate in this study.

Methods: Women will be recruited at ANC visits and at the emergency department and screened against the inclusion criteria. Women will be followed until delivery and evaluated during the consecutives ANC visits. Outcomes will be assessed at the delivery or/and at the discharge if admitted to the hospital for any other causes related with the pregnancy or the malaria. Also, a subpopulation of nonpregnant individuals diagnosed with malaria will be recruited for resistance detection.

Main study parameters/primary endpoints: Incidence of malaria and malaria-related adverse outcomes; impact of the COVID-19 pandemic on malaria care; prevalence of antimalarial resistance against artemisinin derivatives and sulphadoxine-pyrimethamine.

Conditions

Interventions

OTHER

Advanced Analysis of Polymorphism

Assessment of Plasmodium falciparum drug resistance. Target P. falciparum drug resistance genes: Pfk13 propeller, Pfdhfr and Pfdhps. The polymorphisms analysis of the propeller domain of the Pfk13 gene will be performed by PCR amplifications and subsequent sequencing. Analysis of Pfdhfr gene at codons 51, 59, 108 and Pfdhps gene at codon positions 436, 437, 540, 581, 613 will be done by means of amplifications and subsequent Sanger sequencing. Molecular studies will be performed only for research purposes and will have no impact on the clinical management of study patients.

Sponsors & Collaborators

  • University of Bari "Aldo Moro", Bari Italy

    collaborator UNKNOWN

  • Istituto Superiore di Sanità, Rome, Italy.

    collaborator UNKNOWN

  • Catholic University of the Sacred Heart

    collaborator OTHER

  • Doctors with Africa CUAMM, Kampala Uganda

    collaborator UNKNOWN

  • Doctors with Africa-Cuamm, Padua, Italy

    collaborator UNKNOWN

  • Doctors with Africa - CUAMM

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-04-01
Completion
2024-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05348746 on ClinicalTrials.gov