Viewing Study NCT00158548



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Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00158548
Status: COMPLETED
Last Update Posted: 2017-01-12
First Post: 2005-09-08

Brief Title: ACT With Chloroquine Amodiaquine Sulphadoxine-pyrimethamine in Pakistan
Sponsor: London School of Hygiene and Tropical Medicine
Organization: London School of Hygiene and Tropical Medicine

Study Overview

Official Title: Studies on Adding Artesunate to Existing Antimalarial Therapies With Chloroquine Amodiaquine Sulphadoxine-pyrimethamine in Pakistan
Status: COMPLETED
Status Verified Date: 2017-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Chloroquine resistant falciparum malaria in Pakistan is prevalent in every malarious area examined Resistance to the favoured second-line treatment sulphadoxine-pyrimethamine SP is rising fast To avert a repetition of the resistance catastrophe that occurred in SE Asia it is critical to preserve the effective life of SP by using it in combination with artesunate Efficacy of ACT with artesunate in combination with chloroquine SP or amodiaquine for treatment of malaria falciparum or vivax will be examined in malaria patients in Pakistan
Detailed Description: The incidence of falciparum malaria in Pakistan has risen 6-fold over the last 15 years and chloroquine resistance is prevalent in every malarious area examined Chloroquines position as first line treatment must be reconsidered Resistance to the favoured second-line treatment sulphadoxine-pyrimethamine SP is 10 and rising fast It is critical to preserve the effective life of SP by using it in combination with a non-related fast-acting antimalarial such as artesunate AS It is conceivable that use of AS in combination with chloroquine itself might even recover the latters effectiveness and restrain the selection of stronger levels of chloroquine resistance To determine the tolerability and efficacy of AS combination therapy in the subcontinent randomized controlled trials will be conducted by HealthNet International and government staff with technical support from LSHTM in Afghan refugee camps in Pakistan against the current therapies of chloroquine amodiaquine and SP Current policy is to use primaquinePQ as the gametocytocidal drug with CQ or SP It is not clear whether this has any value in the face of high levels of CQ resistance The efficacy of PQ in combination with CQ or SP will be examined in individual randomised trial in comparison with CQ or SP alone

In the past treatment of falciparum and vivax malaria was with chloroquine With development of drug resistance treatment of the two species is diverging and this places higher priority on accurate differential diagnosis which cannot always be met at peripheral health posts There may be advantage in harmonising treatment of the two species with ACT Thus the current treatment for vivax chloroquine shall be compared with that of ACT with artesunate and SP the likely ACT to be adopted for falciparum malaria

Protocol design

Randomised single-blind controlled trials comparing for falciparum malaria 1 artesunate AS and chloroquine CQ vs CQ alone vs CQ and primaquine PQ 2 AS and sulphadoxine-pyrimethamine SP vs SP alone vs SP and PQ 3 AS and amodiaquine AQ vs AQ alone

Randomised single-blind controlled trial comparing for vivax malaria AS and sulphadoxine-pyrimethamine SP vs CQ alone

Patients will be randomly assigned to one of the following treatment groups

CQ day123 placebo day 1 3 vs
CQ day 123 PQ day 1 placebo day 3 vs
CQ day 123 PQ day 3 placebo day 1 vs
CQ day 123 AS day 1 placebo day 3
SP day 1 placebo day 1 vs
SP day 1 AS day 1 vs
SP day 1 PQ day 1
AQ day 123 placebo day 123 vs
AQ day 123 AS day 123

To determine the viability and transmissibility of any gametocytes and also to detect sub-patent gametocytaemias still present after treatment it is also proposed to carry out mosquito feeding studies directly on patients on the 7th day after the start of combination therapy with either CQ CQAS CQPQ SP SPAS SPPQ and to incubate any midgut infections to the oocyst stage To determine the genetic consequences of any selection from the different drugs ie CQ AS or PQ the mosquito midgut infections would be preserved for further genetic studies in UK as would blood samples taken from initial and recrudescent infections

To improve our understanding of the genetic basis of drug resistance we will genotype parasites from blood samples of patients with treatment failure in this study Blood samples of 20 patients from each arm of the study who had parasitological treatment failure will be selected randomly together with midgut infections and analysed for genetic markers of resistance to chloroquine and sulphadoxinepyrimethamine These will be compared with genotypes of pre-treatment infections

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
ITDCVV98 None None None