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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
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Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
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Effective and safe treatment for malaria in pregnancy in India: a randomised controlled trial. 
Scientific Title of Study
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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
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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)
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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

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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

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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
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Malaria in Pregnancy Consortium, Liverpool School of Tropical Medicine, Liverpool 
 
Primary Sponsor
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Name  Malaria in Pregnancy Consortium Liverpool School of Tropical Medicine Liverpool UK 
Address  UK 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor
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Name  Address 
NA   
 
Countries of Recruitment
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  India  
Sites of Study
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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
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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
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Status 
Approved/Obtained 
 
Health Condition / Problems Studied
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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
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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
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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
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Other 
Method of Concealment
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Not Applicable 
Blinding/Masking
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Open Label 
Primary Outcome
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Outcome  TimePoints 
Adequate clinical and parasitological response corrected for new infections by PCR by day 63 post treatment (ACPR63)  Day 63 
 
Secondary Outcome
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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
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Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
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Phase 2/ Phase 3 
Date of First Enrollment (India)
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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
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Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
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Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
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none yet 
Brief Summary
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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. 
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