Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-01 @ 9:06 PM
Study NCT ID:
NCT07122232
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2025-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Thrombocytopenia in Plasmodium Vivax and Falciparum Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D016778', 'term': 'Malaria, Falciparum'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Frequency of malaria-related complications', 'timeFrame': 'Within 7 days of admission', 'description': 'Number of patients developing clinical complications (e.g., acute kidney injury, neurological involvement, anemia, jaundice), stratified by malaria species.'}], 'primaryOutcomes': [{'measure': 'Proportion of patients with thrombocytopenia', 'timeFrame': '0 days', 'description': 'The percentage of patients with platelet counts \\<50×10³/µL at admission, compared between the P. vivax and P. falciparum groups.'}], 'secondaryOutcomes': [{'measure': 'Platelet count recovery over time', 'timeFrame': 'Day 0 to Day 7', 'description': 'Change in mean platelet count at admission, day 3, and day 7, for each group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thrombocytopenia', 'Plasmodium falciparum', 'Malaria complications', 'Platelet count dynamics'], 'conditions': ['Malaria', 'Plasmodium Vivax Infection', 'Plasmodium Falciparum Infection', 'Thrombocytopenia']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare platelet count patterns in patients infected with either Plasmodium vivax or Plasmodium falciparum, the two most common malaria species in Pakistan. Thrombocytopenia (low platelet count) is a common complication of malaria and can help in identifying disease severity. We conducted this research at a tertiary care hospital in Peshawar, Pakistan, from April to September 2023. A total of 171 adult patients with confirmed malaria infections were enrolled. We measured their platelet counts at admission, day 3, and day 7, and analyzed the severity and progression of thrombocytopenia. The study found that while P. vivax was more common, P. falciparum was more likely to cause severe thrombocytopenia. Understanding these differences helps healthcare providers identify high-risk patients earlier and manage malaria more effectively. The study was approved by the institutional review board of Lady Reading Hospital, Peshawar.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (aged 18 and above) presenting to a tertiary care hospital in Peshawar, Pakistan, with confirmed malaria infection. Participants were included based on microscopic confirmation of either Plasmodium vivax or Plasmodium falciparum infection and evaluated for platelet trends and clinical outcomes.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Microscopically confirmed infection with Plasmodium vivax or Plasmodium falciparum\n* Provided written informed consen\n\nExclusion Criteria:\n\n* Mixed-species malaria infection\n* Known hematologic disorders\n* Chronic liver disease\n* Recent blood transfusion\n* Use of anticoagulant medication\n* Incomplete parasitemia data or lost to follow-up'}, 'identificationModule': {'nctId': 'NCT07122232', 'briefTitle': 'Comparative Study of Thrombocytopenia in Plasmodium Vivax and Falciparum Malaria', 'organization': {'class': 'OTHER', 'fullName': 'Nangarhar University'}, 'officialTitle': 'Comparative Analysis of Thrombocytopenia in Plasmodium Vivax and Plasmodium Falciparum Malaria: A Prospective Cross-Sectional Study From a Tertiary Care Hospital in Peshawar, Pakistan', 'orgStudyIdInfo': {'id': 'Ref: No. 617/LRH/MTI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Plasmodium vivax Group', 'description': 'Adult patients (≥18 years) with microscopically confirmed Plasmodium vivax malaria. Platelet counts and clinical data were collected at admission, day 3, and day 7 to assess the frequency and severity of thrombocytopenia.'}, {'label': 'Plasmodium falciparum Group', 'description': 'Adult patients (≥18 years) with microscopically confirmed Plasmodium falciparum malaria. Platelet counts and clinical data were collected at admission, day 3, and day 7 to assess the frequency and severity of thrombocytopenia.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'KPK', 'country': 'Pakistan', 'facility': 'Lady Reading Hospital, Medical Teaching Institution', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Rafiullah Hotak, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nangarhar University faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rafiullah Hotak', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lady Reading Hospital, Pakistan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Student', 'investigatorFullName': 'Rafiullah Hotak', 'investigatorAffiliation': 'Nangarhar University'}}}}