MalariaNCT07122232
Comparative Study of Thrombocytopenia in Plasmodium Vivax and Falciparum Malaria
An observational study of Malaria and Plasmodium Vivax Infection, run by Rafiullah Hotak at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malaria, Plasmodium Vivax Infection, Plasmodium Falciparum Infection
- How many people
- 177 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age 18 years or older
- Microscopically confirmed infection with Plasmodium vivax or Plasmodium falciparum
- Provided written informed consen
Who cannot join
- Mixed-species malaria infection
- Known hematologic disorders
- Chronic liver disease
- Recent blood transfusion
- Use of anticoagulant medication
- Incomplete parasitemia data or lost to follow-up
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lady Reading Hospital, Medical Teaching Institution
Peshawar, KPK, 25000
About this study
Official title: Comparative Analysis of Thrombocytopenia in Plasmodium Vivax and Plasmodium Falciparum Malaria: A Prospective Cross-Sectional Study From a Tertiary Care Hospital in Peshawar, Pakistan
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.
- Keywords
- Thrombocytopenia, Plasmodium falciparum, Malaria complications, Platelet count dynamics
- Medical subject headings
- Malaria, Thrombocytopenia, Malaria, Falciparum
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 |
|---|---|---|
| Plasmodium vivax Group | 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. | |
| Plasmodium falciparum Group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with thrombocytopenia
The percentage of patients with platelet counts <50×10³/µL at admission, compared between the P. vivax and P. falciparum groups.
Measured: 0 days
Secondary outcomes (1)
Platelet count recovery over time
Change in mean platelet count at admission, day 3, and day 7, for each group.
Measured: Day 0 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Apr 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rafiullah Hotak
- Sponsor type
- University, hospital or other
- Collaborators
- Lady Reading Hospital, Pakistan
- Responsible party
- Sponsor-investigator, Rafiullah Hotak, Nangarhar University
- Investigators
- Rafiullah Hotak, MBBS, Principal investigator, Nangarhar University faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122232
- Sponsor's protocol ID
- Ref: No. 617/LRH/MTI
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Thrombocytopenia in Plasmodium Vivax and Plasmodium Falciparum Malaria: A Prospective Cross-Sectional Study From a Tertiary Care Hospital in Peshawar, Pakistan
- ClinicalTrials.gov ID
- NCT07122232
- Acronym / sponsor ID
- Ref: No. 617/LRH/MTI
- Keywords
- Thrombocytopenia, Plasmodium falciparum, Malaria complications, Platelet count dynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Rafiullah HotakUniversity, hospital or other
- Collaborators
- Lady Reading Hospital, Pakistan
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 14 Aug 2025 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasmodium vivax Group | – | –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. |
| Plasmodium falciparum Group | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Microscopically confirmed infection with Plasmodium vivax or Plasmodium falciparum
- Provided written informed consen
Key exclusion criteria (6 listed)
- Mixed-species malaria infection
- Known hematologic disorders
- Chronic liver disease
- Recent blood transfusion
- Use of anticoagulant medication
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
Proportion of patients with thrombocytopenia
Time frame: 0 days
The percentage of patients with platelet counts <50×10³/µL at admission, compared between the P. vivax and P. falciparum groups.
1 secondary outcome
Platelet count recovery over time
Time frame: Day 0 to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Rafiullah Hotak, MBBS principal investigator
Nangarhar University faculty of medicine
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 Malaria and Plasmodium Vivax Infection, run by Rafiullah Hotak at 1 site in Pakistan.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 14 Aug 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients with thrombocytopenia (time frame: 0 days). 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 14 Aug 2025.