| CTRI Number |
CTRI/2012/12/003271 [Registered on: 31/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
01/03/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE-CORRELATIVE STUDY |
| Study Design |
Other |
|
Public Title of Study
|
A CLINICAL STUDY OF SEVERITY(COMPLICATIONS) OF DIFFERENT TYPES OF MALARIA |
|
Scientific Title of Study
|
SPLENOMEGALY AND THROMBOCYTOPENIA - IN CORRELATION WITH THE TYPE AND SEVERITY IN MALARIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEPAK CL |
| Designation |
PG RESIDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE,
FATHER MULLER MEDICAL COLLEGE,
KANKANADY,
MANGALORE,
KARNATAKA,
INDIA.
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9916207061 |
| Fax |
|
| Email |
dr_deepakcl@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
DR SMITHA BHAT |
| Designation |
PROFESSOR |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE,
FATHER MULLER MEDICAL COLLEGE,
KANKANADY,
MANGALORE,
KARNATAKA,
INDIA.
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9845162167 |
| Fax |
|
| Email |
doctorsmitha@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
DEEPAK CL |
| Designation |
PG RESIDENT |
| Affiliation |
FATHER MULLER MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE,
FATHER MULLER MEDICAL COLLEGE,
KANKANADY,
MANGALORE,
KARNATAKA,
INDIA.
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9916207061 |
| Fax |
|
| Email |
dr_deepakcl@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DEEPAK CL |
| Address |
DEPARTMENT OF GENERAL MEDICINE,
FATHER MULLER MEDICAL COLLEGE,
KANKANADY,
MANGALORE, |
| Type of Sponsor |
Other [DEEPAK CL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DEEPAK CL |
FATHER MULLER MEDICAL COLLEGE HOSPITAL |
DEPT OF GENERAL MEDICINE,
4TH FLOOR,
FATHER MULLER MEDICAL COLLEGE HOSPITAL,
FATHER MULLER ROAD,
KANKANADY,
MANGALORE- 575002 Dakshina Kannada KARNATAKA |
9916207061
dr_deepakcl@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Malaria, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group of 18-60 years admitted with smear positive for falciparum/vivax malaria in Father Muller Medical College Hospital will be included in the study. |
|
| ExclusionCriteria |
| Details |
•Patients with a clinical features and/or diagnosis of associated dengue fever, leptospirosis and typhoid fever.
•Patients with immunocompromised status or receiving immunosuppressive treatment.
•Chronic liver disease.
•Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To find whether thrombocytopenia can be used as an early indicator of severity in malaria.
2.To find the association between degree of thrombocytopenia and splenomegaly in malaria.
3.To correlate thrombocytopenia and splenomegaly with type and severity in malaria.
|
Single time point at the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Malaria is a common communicable disease and is a major
public health problem in India, resulting in high morbidity and mortality.
Splenomegaly and thrombocytopenia are common findings in malaria.
Thrombocytopenia is present in 80% of the patients with malaria and some
studies show that thrombocytopenia in malaria closely correlates with the
degree of parasitemia. However, thrombocytopenia is not included in the WHO
criteria for severe malaria. This study aims to find whether thrombocytopenia
can be an indicator of severe malaria as it is a hematological parameter that
is present even before other features of severe malaria set in. It also aims to
find the association between degree of thrombocytopenia and splenomegaly in
malaria.
Severe malaria is defined according
to the WHO guidelines. The presence of one or more of the following clinical or
laboratory features classifies the adult patient as suffering from severe
malaria. Clinical features like a) impaired consciousness or unrousable coma,
b) prostration (generalized weakness so that the patient is unable to walk or
sit up without assistance), c) multiple convulsions (>2 episodes in 24hours),
d) deep breathing, respiratory distress (acidotic breathing), e) circulatory
collapse or shock (systolic BP <70mmHg), f) clinical jaundice plus evidence
of other vital organ dysfunction, g) hemoglobinuria, h) abnormal spontaneous
bleeding, i) pulmonary edema (radiological). Laboratory findings like a)
hypoglycemia (blood glucose <40mg/dl), b) metabolic acidosis (plasma
bicarbonate <15mmol/l), c) normocytic anemia (Hb <5g/dl, packed cell
volume <15%), d) hemoglobinuria, e) hyperlactataemia (lactate >5mmol/l),
f) renal impairment (serum creatinine >3mg/dl), g) hyperparasitemia
(2%/100,000/μl in low intensity transmission areas or >5% or 250,000/μl in
high intensity transmission areas).
Thrombocytopenia by definition is
an abnormally low amount of platelets, less than 1,50,000 per microliter of
blood.
|