| CTRI Number |
CTRI/2009/091/001055 [Registered on: 11/01/2010] |
| Last Modified On: |
26/09/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Effective and safe treatment for malaria in pregnancy in India: a randomised controlled trial. |
Scientific Title of Study
Modification(s)
|
A Phase II/III randomised clinical trial of the efficacy & safety of artesunate suplhadoxine pyrimethamine and artesunate mefloquine to treat uncomplicated falciparum malaria in pregnancy |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| Amendment2 dated 10.8.2011 |
Protocol Number |
| Protocol version 0.1; 01.06.2008 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Anup Anvikar |
| Designation |
Scientist D |
| Affiliation |
National Institute of Malaria Research |
| Address |
National Institute of Malaria Research
Sector 8
Dwarka
New Delhi
Sector 8
Dwarka
New Delhi 110077
New Delhi
DELHI
110077
India |
| Phone |
01125307122 |
| Fax |
01125361090 |
| Email |
anvikar@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anupkumar Anvikar |
| Designation |
Scientist D |
| Affiliation |
|
| Address |
National Institute of Malaria Research
Sector 8
Dwarka
New Delhi
Sector 8, Dwarka, Delhi-110077
New Delhi
DELHI
110077
India |
| Phone |
01125307122 |
| Fax |
01125361090 |
| Email |
anvikar@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Anupkumar Anvikar |
| Designation |
Scientist D |
| Affiliation |
National Institute of Malaria Research |
| Address |
National Institute of Malaria Research
Sector 8
Dwarka
New Delhi
Sector 8
Dwarka
New Delhi 110077
New Delhi
DELHI
110077
India |
| Phone |
01125307122 |
| Fax |
01125361090 |
| Email |
anvikar@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Malaria in Pregnancy Consortium, Liverpool School of Tropical Medicine, Liverpool |
|
Primary Sponsor
Modification(s)
|
| Name |
Malaria in Pregnancy Consortium Liverpool School of Tropical Medicine Liverpool UK |
| Address |
UK |
| Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tushar Arya |
NIMR FS and Mahadevi Birla Hospital, Ranchi, Jharkhand, India |
Ranchi NIMR FS and Mahadevi Birla Hospital
Ranchi
Jharkhand
Ranchi
JHARKHAND |
9334152132
mipranchi.2012@gmail.com |
| Dr SK Mishra |
ISPAT General Hospital |
Rourkela 769002
Sundargarh
ORISSA |
06614648252
sarojkantimishra@rediffmail.com |
| Dr Rajesh Mohanty |
Tata Main Hospital |
Jamshedpur,-831001
Purbi Singhbhum
JHARKHAND |
09431389500
drrajeshtmh@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee, National Institute of Malaria Research (ICMR), Sector 8, Dwarka, New Delhi- 77 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
This study will be conducted with symptomatic or asymptomatic uncomplicated falciparum malaria in 2nd and 3rd trimester during pregnancy, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
1.Artesunate 200mg x 3 days + mefloquine 440mg x 3 days. |
Oral route
Artesunate 200mg on day1 mefloquine 440mg on day1
Artesunate 200mg on day2 mefloquine 440mg on day2
Artesunate 200mg on day3 mefloquine 440mg on day3 |
| Comparator Agent |
Artesunate 200mgx 3days
Suphadoxine 1500mg + pyremethamine 75mg on day1
|
Oral route
Artesunate 200mg on day1
Suphadoxine 1500mg + pyremethamine 75mg on day1
Artesunate 200mg on day2 Artesunate 200mg on day3 |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
(i) Pregnant women of all parities having P falciparum parasitaemia (mono infection)in 2nd and 3rd trimester
|
|
| ExclusionCriteria |
| Details |
(i) Hb <7; (ii) gestation <12 or >36 wks; (iii) age <18 years (iv) abnormal liver or renal function; (v) history of taking an antimalarial within the last 7 days; (vi) history of allergy to any of the study drugs; (vii) taking part in any other clinical trials of drugs or vaccines; (viii) severe malaria (based either on clinical presentation or parasitological grounds); (ix) Other conditions requiring hospitalization or evidence of severe concomitant infection; (x) Known chronic disease (cardiac, haemoglobinopathy); (xi) History of convulsions during the present illness or history of psychiatric disorder or seizures (xii) vivax malaria or mixed infection
Inclusion criteria
|
|
Method of Generating Random Sequence
Modification(s)
|
Other |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Adequate clinical and parasitological response corrected for new infections by PCR by day 63 post treatment (ACPR63) |
Day 63 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Adverse events both clinical and biochemical
2.Birth outcomes
3.Re-infection by day 63
4.Congenital malformations detected within 7 days of birth
|
Birth outcomes and followup upto 42 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
01/11/2010 |
| 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
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a phase II/III randomized clinical trial to test the efficacy and safety of artesunate + mefloquine to treat uncomplicated falciparum malaria in pregnancy. In view of widespread CQ resistance in P. falciparum, Artemisinin based combination therapy is recommended as first line treatment for falciparum malaria globally and in India. Although WHO recommends use of ACT in 2nd and 3rd trimester in pregnancy, it is not used in India till date due to lack of data on safety and efficacy in this valuable group. The present studies will generate valuable data on efficacy of two ACTs in malaria in pregnancy and will help in revision of drug policy in India. In response to the high rate of CQ failure, National Drug Policy recommends to change the first line drug for treatment of falciparum malaria from chloroquine (CQ) to artesunate (AS) + sulphadoxine-pyrimethamine (SP). However there is lack of data for recommending ACT treatment of MIP. Thus studies to identify effective and safe drugs for treatment of falciparum malaria. |