| CTRI Number |
CTRI/2019/08/020575 [Registered on: 06/08/2019] Trial Registered Prospectively |
| Last Modified On: |
05/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Antimalarial Drug resistance study in West Bengal |
|
Scientific Title of Study
|
Surveillance for artemisinin resistance in West Bengal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anupkumar Anvikar |
| Designation |
Scientist F |
| Affiliation |
ICMR National Institute of malaria Research |
| Address |
Epidemiology and clinical division room no 432
sector 8
Dwarka
New Delhi
Epidemiology and clinical research division room no 432
sector 8
Dwarka
New Delhi
South West
DELHI
110077
India |
| Phone |
01125307122 |
| Fax |
01125307177 |
| Email |
anvikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupkumar Anvikar |
| Designation |
Scientist F |
| Affiliation |
ICMR National Institute of malaria Research |
| Address |
Epidemiology and cklinical research division room no 432
sector 8
Dwarka
New Delhi
Epidemiology and clinical research division room no 432
sector 8
Dwarka
New Delhi
South West
DELHI
110077
India |
| Phone |
01125307122 |
| Fax |
01125307177 |
| Email |
anvikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupkumar Anvikar |
| Designation |
Scientist F |
| Affiliation |
ICMR National Institute of malaria Research |
| Address |
Epidemiology and clinical research division room no 432
sector 8
Dwarka
New Delhi
Epidemiology and Clinical research division room no 432
sector 8
Dwarka
New Delhi
South West
DELHI
110077
India |
| Phone |
01125307122 |
| Fax |
01125307177 |
| Email |
anvikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian council of medical research V Ramalingaswami Bhawan PO Box No 4911
Ansari Nagar New Delhi 110029 India |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Ansari nagar New Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santanu Tripathi |
Calcutta School of Tropical Medicine |
Department of clinical pharmacology third floor 108 Chittaranjan Avenue
kolkotta
Kolkata
WEST BENGAL |
9230566771
tripathi.santanu@gmail.com |
| Dr Anup Anvikar |
ICMR National Institute of Malaria Research |
Epidemiology and clinical research division rm 432 Sector 8 Dwarka
South West
DELHI |
9868312581
01125307177
anvikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B509||Plasmodium falciparum malaria, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Mono infection with P falciparum detected by microscopy
parasitaemia of 1000 to 100000 per µl asexual forms
presence of axillary more or equal to 37.5 °C or history of fever during the past 48 h
ability to swallow oral medication
ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
Informed consent from the patient or from a parent or guardian in the case of children.
|
|
| ExclusionCriteria |
| Details |
presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO
mixed or mono-infection with another Plasmodium species detected by microscopy
presence of severe malnutrition
presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases
regular medication, which may interfere with antimalarial pharmacokinetics
history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatment and
a positive pregnancy test or breastfeeding;
unable to or unwilling to take contraceptives for women of child-bearing age
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the evidence of artemisinin resistance in P falciparum malaria in eastern India. Efficacious antimalarial medicines are critical to malaria control. Continuous monitoring of their efficacy is needed to inform treatment policies in malaria-endemic countries, and to ensure early detection of, and response to, drug resistance |
28 days followup period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe Kelch13 mutation |
28 days |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The national antimalarial drug policy
recommends the use of ACT for treatment of falciparum malaria.
Artemether-lumefantrine is recommended for north eastern states, while
artesunate+sulphadoxine pyrimethamine (AS+SP) is recommended in remaining
states. Loss of efficacy to artemisinins can derail current malaria control and
elimination efforts. As of now both the ACTs have been found to be efficacious.
Therapeutic efficacy studies carried out in the past decades have not shown
evidence of artemisinin resistance in India. However, recently, Das et al reported
the report of emergence of artemisinin resistance from West Bengal. Although
there are questions on definition of artemisinin resistance used by the
investigators, there is definite need to investigate and conduct specific
detailed study in addition to TES study for possible artemisinin resistance in
the state to prove or disprove the claims. We propose to conduct study in West
Bengal by clinical, molecular and transcriptomic analysis. |